<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03246659</url>
  </required_header>
  <id_info>
    <org_study_id>GRAN-T-MTC</org_study_id>
    <nct_id>NCT03246659</nct_id>
  </id_info>
  <brief_title>Radiolabelled CCK-2/Gastrin Receptor Analogue for Personalized Theranostic Strategy in Advanced MTC</brief_title>
  <acronym>GRAN-T-MTC</acronym>
  <official_title>Phase I Clinical Trial Using a Novel CCK-2/Gastrin Receptor-localizing Radiolabelled Peptide Probe for Personalized Diagnosis and Therapy of Patients With Progressive or Metastatic Medullary Thyroid Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Paola Anna Erba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jagiellonian University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital Freiburg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical University Innsbruck</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Medical Centre Ljubljana</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>NATIONAL CENTRE FOR NUCLEAR RESEARCH, Poland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Erasmus Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>INRASTES, NCSR Demokritos, Athens, Greece</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Azienda Ospedaliero, Universitaria Pisana</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is a phase I multicentre randomized, open, parallel-arm clinical trial conducted to&#xD;
      investigate the IMP, namely 111In-CP04.&#xD;
&#xD;
      The study consists of preclinical (to establish a clinically useful formulation for the&#xD;
      radiolabelled peptide CP04), and a clinical step. The main objective of the clinical part of&#xD;
      the project is to establish the safety of i.v. administration of a high peptide amount and to&#xD;
      assess the tracer biodistribution and dosimetry in MTC and normal tissues and to determine&#xD;
      critical organs as well as the evaluation of the potential of CCK2 receptor scintigraphy to&#xD;
      detect cancer lesions for both low (10ug) and high (50ug) peptide amount and the decrease of&#xD;
      kidney dose after co-administration of gelofusine /gelaspan as a nephroprotective agent. To&#xD;
      achieve this, the following study design has been accepted: the first 4 patients will receive&#xD;
      2 peptide amount of CP04: low peptide amount (for diagnostic purpose) and high peptide amount&#xD;
      (for therapeutic purpose) of CP04. If no SAE is present, the remaining pts will be randomized&#xD;
      for 2 arms: high peptide amount of 111In-CP04 with and without gelofusine/gelaspan infusion.&#xD;
&#xD;
      It is expected that CCK-2/gastrin receptor imaging will become a valid diagnostic method for&#xD;
      a specific non-invasive staging and follow-up of patients with MTC, and treatment of&#xD;
      recurrent and disseminated disease will be more efficient with minimized nephro- and&#xD;
      myelotoxicity (if 111In labelled).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main goal of the study is to expand cancer preclinical research results on the usefulness&#xD;
      of CCK-2/gastrin receptor in clinical practice. On the basis of last few years preclinical&#xD;
      research outcome on new biomarkers, conjugate CP04 was chosen on the basis of its good&#xD;
      stability and affinity to CCK-2/gastrin receptor in vitro, as well as its favourable&#xD;
      biodistribution and pharmacodynamic properties in vivo, preclinically. Within this project&#xD;
      the tracer may get a chance to be introduced to clinical practice as a more selective and&#xD;
      efficient tool for the diagnosis, early detection and therapy of recurrent and metastatic&#xD;
      MTC.&#xD;
&#xD;
      Furthermore, the project may become the first step to establish a new, more effective&#xD;
      strategy for the treatment of MTC patients leading to reduction of incidence and mortality as&#xD;
      well as improvement of quality of life. CCK-2/gastrin receptors may become viable targets for&#xD;
      radionuclide scintigraphy and radionuclide therapy, similarly to somatostatin receptors which&#xD;
      have been instrumental to establish nuclear medicine efficacy in clinical practice. Achieving&#xD;
      key project objectives (i.e. investigation of patients after administration of high peptide&#xD;
      amount of the CCK-2/gastrin receptor labelled compound, performing complete patient peptide&#xD;
      assessment and research nephrotoxicity in patients with or without administration for&#xD;
      nephroprotective agent gelofusine/gelaspan), we will be able to define the exact molecular&#xD;
      profile of an individual patient and tumour. Eventually, safe and efficacious personalized&#xD;
      treatment will be planned using radiolabelled CCK-2/gastrin ligands of higher therapeutic&#xD;
      efficacy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2016</start_date>
  <completion_date type="Actual">November 2018</completion_date>
  <primary_completion_date type="Actual">November 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of CP04</measure>
    <time_frame>4 months</time_frame>
    <description>Safety of intravenous administration of CP04 at low peptide amount (for diagnostic purpose) and high peptide amount (for therapeutic purpose) radiolabelled with 200±10% MBq of 111In will be assessed by type, frequency, severity, timing and relation to the studied radiopharmaceutical Safety of intravenous administration of CP04 at low peptide amount (for diagnostic purpose) and high peptide amount (for therapeutic purpose) radiolabelled with 200±10% MBq of 111In will be assessed by type, frequency, severity, timing and relation to the studied radiopharmaceutical administration of adverse events and laboratory abnormalities based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Uptake of 111In-CP04 in tumor and other tissues</measure>
    <time_frame>72 hours from 111In-CP04 injection</time_frame>
    <description>The radioactivity uptake of 111In-CP04 will be assessed in the tumor lesions and in other tissues naturally expressing CCK2 receptors, based on the planar and SPECT/CT images (expressed as the ratio of counts over the region of interest (ROI) selected over the target tissue compared to the counts over the equivalent region in patient's body which is not taking up the 111In-CP04), otherwise described as target to non target ratio T/N</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics of 111In-CP04</measure>
    <time_frame>72 hours from 111In-CP04 injection</time_frame>
    <description>Area under the selected organs concentration versus time curve</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics of 111In-CP04</measure>
    <time_frame>72 hours from 111In-CP04 injection</time_frame>
    <description>Area under the blood concentration versus time curve</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnostic sensitivity/specificity of 111In-CP04 to detect cancer lesions</measure>
    <time_frame>3 years</time_frame>
    <description>Diagnostic sensitivity/specificity of 111In-CP04 to detect cancer lesions for both diagnostic and therapeutic peptide amount by Qualitative Visual Analysis (number of patients with uptake at site of lesion, the number of lesions with abnormal tracer uptake at scintigraphy, the number and site of lesions with pathological uptake detected per verifiable organ or body region relative to those detected</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of pharmacokinetic/imaging effect of low and high peptide amount</measure>
    <time_frame>3 years</time_frame>
    <description>To evaluate the influence of a low amount of CP04 peptide on the high amount of peptide vs. the high amount of peptide alone on tumour and organ uptake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gelofusine/gelaspan injection and CP04 kidney uptake</measure>
    <time_frame>3 years</time_frame>
    <description>To investigate the relative decrease of kidney dose after co-administration of nephroprotective agent - gelofusine/gelaspan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dosimetry</measure>
    <time_frame>72 hours from 111In-CP04 injection</time_frame>
    <description>Pharmacokinetics data for the assessment of organ and tissue radiation absorbed doses..</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Medullary Thyroid Carcinoma</condition>
  <arm_group>
    <arm_group_label>arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>111In-CP04</description>
  </arm_group>
  <arm_group>
    <arm_group_label>arm 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>111In-CP04 with co-administration of gelofusine/gelaspan</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>111In-CP04</intervention_name>
    <description>Radiopharmaceutical preparation</description>
    <arm_group_label>arm 1</arm_group_label>
    <other_name>111In-CP04 (DOTA-(DGlu)6-Ala-Tyr-Gly-Trp-Met-Asp-Phe-NH2</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>111In-CP04 with co-administration of gelofusine/gelaspan</intervention_name>
    <description>Radiopharmaceutical preparation with co-administration of gelofusine/gelaspan</description>
    <arm_group_label>arm 2</arm_group_label>
    <other_name>111In-CP04 (DOTA-(DGlu)6-Ala-Tyr-Gly-Trp-Met-Asp-Phe-NH2</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Related to the medullary cancer of the thyroid:&#xD;
&#xD;
          1. Histologically documented medullary cancer of the thyroid.&#xD;
&#xD;
          2. Presence of more than one distant or nodal, surgically untreatable metastases&#xD;
             confirmed with either 18F-FDG PET/CT or enhanced-CT or MRI OR&#xD;
&#xD;
          3. Doubling time (DT) of serum calcitonin level less than two years prior to study entry&#xD;
             and negative imaging.&#xD;
&#xD;
          4. Karnofsky performance status &gt; 50%.&#xD;
&#xD;
          5. Life expectancy of more than 6 months.&#xD;
&#xD;
             Related to the patient:&#xD;
&#xD;
          6. Male or female patients aged &gt;18 years without upper age limit.&#xD;
&#xD;
          7. Ability to understand and willingness to sign a written informed consent document.&#xD;
&#xD;
          8. Written informed consent obtained according to international guidelines and local&#xD;
             laws.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Related to the MTC:&#xD;
&#xD;
          1. Patients with surgically treatable medullary thyroid cancer.&#xD;
&#xD;
          2. Patients with history of second malignancy other than basal cell carcinoma of the&#xD;
             skin.&#xD;
&#xD;
             Related to previous or concomitant therapies :&#xD;
&#xD;
          3. Participation in any other investigational trial within 3 months of study entry.&#xD;
&#xD;
          4. Previous external beam radiation therapy within two years.&#xD;
&#xD;
          5. Organ allograft requiring immunosuppressive therapy.&#xD;
&#xD;
             Related to the patient:&#xD;
&#xD;
          6. Pregnancy, breast-feeding.&#xD;
&#xD;
          7. Known hypersensitivity to gastrin analogues.&#xD;
&#xD;
          8. Patients with concurrent illnesses that might preclude study completion or interfere&#xD;
             with study results.&#xD;
&#xD;
          9. Patients with bladder outflow obstruction or unmanageable urinary incontinence.&#xD;
&#xD;
         10. Clinical diagnosis of disseminated intravascular coagulation.&#xD;
&#xD;
         11. Serum creatinine &gt;170 μmol/L, GFR &lt; 40 mL/min&#xD;
&#xD;
         12. Known history of hypersensitivity to gelofusine /gelaspan or any other&#xD;
             contraindications to gelofusine/gelaspan infusion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paola Anna Erba, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Ospedaliero, Universitaria Pisana</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Nuclear Medicine, Innsbruck Medical University</name>
      <address>
        <city>Innsbruck</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Nuclear Medicine, University Hospital Freiburg</name>
      <address>
        <city>Freiburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus University Rotterdam</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Endocrinology, Jagiellonian University Medical College</name>
      <address>
        <city>Kraków</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Nuclear Medicine, University Medical Centre Ljubljana</name>
      <address>
        <city>Ljubljana</city>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Germany</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Slovenia</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4948680/</url>
    <description>Preclinical pharmacokinetics, biodistribution, radiation dosimetry and toxicity studies required for regulatory approval of a phase I clinical trial with 111In-CP04 in medullary thyroid carcinoma patients</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4817208/</url>
    <description>From preclinical development to clinical application: Kit formulation for radiolabelling the minigastrin analogue CP04 with In-111 for a first-in-human clinical trial</description>
  </link>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>March 19, 2020</last_update_submitted>
  <last_update_submitted_qc>March 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Ospedaliero, Universitaria Pisana</investigator_affiliation>
    <investigator_full_name>Paola Anna Erba</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>medullary thyroid carcinoma</keyword>
  <keyword>MTC</keyword>
  <keyword>new gastrin analog</keyword>
  <keyword>111In-CP04</keyword>
  <keyword>CP04 indium</keyword>
  <keyword>personalised diagnostics</keyword>
  <keyword>personalised therapy</keyword>
  <keyword>theranostics</keyword>
  <keyword>advanced MTC</keyword>
  <keyword>CCK-2/gastrin receptor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Thyroid Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Neuroendocrine</mesh_term>
    <mesh_term>Thyroid Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polygeline</mesh_term>
    <mesh_term>Gastrins</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03246659
org study id: GRAN-T-MTC
nct id: NCT03246659
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study is a phase I multicentre randomized, open, parallel-arm clinical trial conducted to
      investigate the IMP, namely 111In-CP04.

      The study consists of preclinical (to establish a clinically useful formulation for the
      radiolabelled peptide CP04), and a clinical step. The main objective of the clinical part of
      the project is to establish the safety of i.v. administration of a high peptide amount and to
      assess the tracer biodistribution and dosimetry in MTC and normal tissues and to determine
      critical organs as well as the evaluation of the potential of CCK2 receptor scintigraphy to
      detect cancer lesions for both low (10ug) and high (50ug) peptide amount and the decrease of
      kidney dose after co-administration of gelofusine /gelaspan as a nephroprotective agent. To
      achieve this, the following study design has been accepted: the first 4 patients will receive
      2 peptide amount of CP04: low peptide amount (for diagnostic purpose) and high peptide amount
      (for therapeutic purpose) of CP04. If no SAE is present, the remaining pts will be randomized
      for 2 arms: high peptide amount of 111In-CP04 with and without gelofusine/gelaspan infusion.

      It is expected that CCK-2/gastrin receptor imaging will become a valid diagnostic method for
      a specific non-invasive staging and follow-up of patients with MTC, and treatment of
      recurrent and disseminated disease will be more efficient with minimized nephro- and
      myelotoxicity (if 111In labelled).
The main goal of the study is to expand cancer preclinical research results on the usefulness
      of CCK-2/gastrin receptor in clinical practice. On the basis of last few years preclinical
      research outcome on new biomarkers, conjugate CP04 was chosen on the basis of its good
      stability and affinity to CCK-2/gastrin receptor in vitro, as well as its favourable
      biodistribution and pharmacodynamic properties in vivo, preclinically. Within this project
      the tracer may get a chance to be introduced to clinical practice as a more selective and
      efficient tool for the diagnosis, early detection and therapy of recurrent and metastatic
      MTC.

      Furthermore, the project may become the first step to establish a new, more effective
      strategy for the treatment of MTC patients leading to reduction of incidence and mortality as
      well as improvement of quality of life. CCK-2/gastrin receptors may become viable targets for
      radionuclide scintigraphy and radionuclide therapy, similarly to somatostatin receptors which
      have been instrumental to establish nuclear medicine efficacy in clinical practice. Achieving
      key project objectives (i.e. investigation of patients after administration of high peptide
      amount of the CCK-2/gastrin receptor labelled compound, performing complete patient peptide
      assessment and research nephrotoxicity in patients with or without administration for
      nephroprotective agent gelofusine/gelaspan), we will be able to define the exact molecular
      profile of an individual patient and tumour. Eventually, safe and efficacious personalized
      treatment will be planned using radiolabelled CCK-2/gastrin ligands of higher therapeutic
      efficacy.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of CP04
time frame: 4 months
description: Safety of intravenous administration of CP04 at low peptide amount (for diagnostic purpose) and high peptide amount (for therapeutic purpose) radiolabelled with 200±10% MBq of 111In will be assessed by type, frequency, severity, timing and relation to the studied radiopharmaceutical Safety of intravenous administration of CP04 at low peptide amount (for diagnostic purpose) and high peptide amount (for therapeutic purpose) radiolabelled with 200±10% MBq of 111In will be assessed by type, frequency, severity, timing and relation to the studied radiopharmaceutical administration of adverse events and laboratory abnormalities based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
measure: Uptake of 111In-CP04 in tumor and other tissues
time frame: 72 hours from 111In-CP04 injection
description: The radioactivity uptake of 111In-CP04 will be assessed in the tumor lesions and in other tissues naturally expressing CCK2 receptors, based on the planar and SPECT/CT images (expressed as the ratio of counts over the region of interest (ROI) selected over the target tissue compared to the counts over the equivalent region in patient's body which is not taking up the 111In-CP04), otherwise described as target to non target ratio T/N
measure: Pharmacokinetics of 111In-CP04
time frame: 72 hours from 111In-CP04 injection
description: Area under the selected organs concentration versus time curve
measure: Pharmacokinetics of 111In-CP04
time frame: 72 hours from 111In-CP04 injection
description: Area under the blood concentration versus time curve
measure: Diagnostic sensitivity/specificity of 111In-CP04 to detect cancer lesions
time frame: 3 years
description: Diagnostic sensitivity/specificity of 111In-CP04 to detect cancer lesions for both diagnostic and therapeutic peptide amount by Qualitative Visual Analysis (number of patients with uptake at site of lesion, the number of lesions with abnormal tracer uptake at scintigraphy, the number and site of lesions with pathological uptake detected per verifiable organ or body region relative to those detected
measure: Comparison of pharmacokinetic/imaging effect of low and high peptide amount
time frame: 3 years
description: To evaluate the influence of a low amount of CP04 peptide on the high amount of peptide vs. the high amount of peptide alone on tumour and organ uptake
measure: Gelofusine/gelaspan injection and CP04 kidney uptake
time frame: 3 years
description: To investigate the relative decrease of kidney dose after co-administration of nephroprotective agent - gelofusine/gelaspan
measure: Dosimetry
time frame: 72 hours from 111In-CP04 injection
description: Pharmacokinetics data for the assessment of organ and tissue radiation absorbed doses..
arm group label: arm 1
arm group type: Experimental
description: 111In-CP04
arm group label: arm 2
arm group type: Experimental
description: 111In-CP04 with co-administration of gelofusine/gelaspan
intervention type: Drug
intervention name: 111In-CP04
description: Radiopharmaceutical preparation
arm group label: arm 1
other name: 111In-CP04 (DOTA-(DGlu)6-Ala-Tyr-Gly-Trp-Met-Asp-Phe-NH2
intervention type: Drug
intervention name: 111In-CP04 with co-administration of gelofusine/gelaspan
description: Radiopharmaceutical preparation with co-administration of gelofusine/gelaspan
arm group label: arm 2
other name: 111In-CP04 (DOTA-(DGlu)6-Ala-Tyr-Gly-Trp-Met-Asp-Phe-NH2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paola Anna Erba, Professor
role: Principal Investigator
affiliation: Azienda Ospedaliero, Universitaria Pisana
facility: 
facility: 
facility: 
facility: 
facility: 
country: Austria
country: Germany
country: Netherlands
country: Poland
country: Slovenia
url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4948680/
description: Preclinical pharmacokinetics, biodistribution, radiation dosimetry and toxicity studies required for regulatory approval of a phase I clinical trial with 111In-CP04 in medullary thyroid carcinoma patients
url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4817208/
description: From preclinical development to clinical application: Kit formulation for radiolabelling the minigastrin analogue CP04 with In-111 for a first-in-human clinical trial
responsible party type: Sponsor-Investigator
investigator affiliation: Azienda Ospedaliero, Universitaria Pisana
investigator full name: Paola Anna Erba
investigator title: Professor
mesh term: Carcinoma
mesh term: Thyroid Neoplasms
mesh term: Carcinoma, Neuroendocrine
mesh term: Thyroid Diseases
mesh term: Polygeline
mesh term: Gastrins
sharing ipd: No