xml: <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/NCT06016855</url>
    </required_header>
    <id_info>
      <org_study_id>VICCGI2283</org_study_id>
      <secondary_id>NCI-2023-05914</secondary_id>
      <nct_id>NCT06016855</nct_id>
    </id_info>
    <brief_title>Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy in Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors</brief_title>
    <official_title>Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy (PRRT) in Patients With Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Vanderbilt-Ingram Cancer Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Vanderbilt-Ingram Cancer Center</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This phase IV trial evaluates how well giving standard of care (SOC) peptide receptor&#xD;
        radionuclide therapy (PRRT) after SOC surgical removal of as much tumor as possible&#xD;
        (debulking surgery) works in treating patients with grade 1 or 2, somatostatin receptor&#xD;
        (SSTR) positive, gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have spread&#xD;
        from where they first started (primary site) to the liver (hepatic metastasis). Lutetium Lu&#xD;
        177 dotatate is a radioactive drug that uses targeted radiation to kill tumor cells. Lutetium&#xD;
        Lu 177 dotatate includes a radioactive form (an isotope) of the element called lutetium. This&#xD;
        radioactive isotope (Lu-177) is attached to a molecule called dotatate. On the surface of&#xD;
        GEP-NET tumor cells, a receptor called a somatostatin receptor binds to dotatate. When this&#xD;
        binding occurs, the lutetium Lu 177 dotatate drug then enters somatostatin receptor-positive&#xD;
        tumor cells, and radiation emitted by Lu-177 helps kill the cells. Giving lutetium Lu 177&#xD;
        dotatate after surgical debulking may better treat patients with grade 1/2 GEP-NETs&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        PRIMARY OBJECTIVES:&#xD;
  &#xD;
        I. To measure objective response rate of a combination standard of care treatment in&#xD;
        gastroenteropancreatic neuroendocrine tumors by initiating lutetium Lu 177 dotatate within 90&#xD;
        days of surgical debulking.&#xD;
  &#xD;
        II. To assess the radiomic profile including somatostatin receptor standardized uptake values&#xD;
        (SSTR SUV) of large and non-large tumors in study patients)&#xD;
  &#xD;
        III: To assess the safety and tolerability of peptide receptor radionuclide therapy (PRRT)&#xD;
        post-surgical debulking in patients on study.&#xD;
  &#xD;
        IV. To assess the tumor genomic profile of large, resected tumors from patients and assess&#xD;
        for signatures of radioresistance.&#xD;
  &#xD;
        OUTLINE:&#xD;
  &#xD;
        Patients undergo surgical debulking on day 0 and receive lutetium Lu 177 dotatate (177Lu&#xD;
        dotatate) intravenously (IV) over 30 to 40 minutes on day 1 of each cycle. Treatment repeats&#xD;
        every 56 days for up to 4 cycles in the absence of disease progression or unacceptable&#xD;
        toxicity. Patients undergo computed tomography (CT) scan or magnetic resonance imaging (MRI)&#xD;
        throughout the trial, and undergo copper Cu 64 dotatate positron emission tomography/CT&#xD;
        (dotatate PET/CT) during screening and on study.&#xD;
  &#xD;
        After completion of study treatment, patients are followed up at 30-37 days after last dose&#xD;
        and then every 3 months for 2 years.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">March 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">March 31, 2025</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Somatostatin receptor standardized uptake values (SSTR SUV)</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>SSTR SUV (not limited to but including measures such as SSTR SUV max, SSTR SUV mean) will be estimated for the patients undergoing post-operative research dotatate scans and compared to values from peptide receptor radionuclide therapy (PRRT) eligibility-conferring dotatate scans in these same patients. These quantitative analytics will be performed by central review. Changes in SSTR SUV values will be analyzed with summary statistics.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Progression-free survival</measure>
      <time_frame>From the start of PRRT to the date the patient progresses radiographically or succumbs to the disease, assessed up to 2 years</time_frame>
      <description>Will be estimated by the Kaplan-Meier method.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Overall response rate</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Will be estimated by measuring the number of patients who achieve a complete response or partial response by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria on restaging computed tomography or magnetic resonance imaging scans =&lt; 6 months from PRRT completion, from the total number of patients who received the study treatment and possessed measurable disease post-surgical debulking. The number of patients who possessed measurable disease which did not meet RECIST 1.1 eligibility criteria post-surgical debulking will also be recorded.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Overall survival</measure>
      <time_frame>From the start of PRRT to the date the patient progresses radiographically or succumbs to the disease, assessed up to 2 years</time_frame>
      <description>Will be estimated by the Kaplan-Meier method.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of adverse events</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Toxicity will be estimated by documenting the grade 3/4 adverse events, according to Common Terminology Criteria for Adverse Events version 5.0, experienced by study patients.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Gene mutations</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Mutations in genes associated with radioresistance (defined from other malignancies) and other mutations in large resected neuroendocrine tumors will be recorded. Mutations will be described descriptively.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">6</enrollment>
    <condition>Digestive System Neuroendocrine Tumor G1</condition>
    <condition>Digestive System Neuroendocrine Tumor G2</condition>
    <condition>Metastatic Digestive System Neuroendocrine Neoplasm</condition>
    <condition>Metastatic Malignant Neoplasm in the Liver</condition>
    <condition>Pancreatic Neuroendocrine Tumor G1</condition>
    <condition>Pancreatic Neuroendocrine Tumor G2</condition>
    <arm_group>
      <arm_group_label>Treatment (surgical debulking, 177Lu dotatate)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients undergo surgical debulking on day 0 and receive 177Lu dotatate IV over 30 to 40 minutes on day 1 of each cycle. Treatment repeats every 56 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI throughout the trial, and undergo dotatate PET/CT during screening and on study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Tumor Debulking</intervention_name>
      <description>Undergo surgical debulking</description>
      <arm_group_label>Treatment (surgical debulking, 177Lu dotatate)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Lutetium Lu 177 Dotatate</intervention_name>
      <description>Given by IV</description>
      <arm_group_label>Treatment (surgical debulking, 177Lu dotatate)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Computed Tomography</intervention_name>
      <description>Undergo Computed Tomography</description>
      <arm_group_label>Treatment (surgical debulking, 177Lu dotatate)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Magnetic Resonance Imaging</intervention_name>
      <description>Undergo Magnetic Resonance Imaging</description>
      <arm_group_label>Treatment (surgical debulking, 177Lu dotatate)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Copper Cu 64 Dotatate</intervention_name>
      <description>Given by IV</description>
      <arm_group_label>Treatment (surgical debulking, 177Lu dotatate)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Positron Emission Tomography</intervention_name>
      <description>Undergo Positron Emission Tomography</description>
      <arm_group_label>Treatment (surgical debulking, 177Lu dotatate)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Signed and dated written informed consent&#xD;
  &#xD;
            -  Male or female &gt;= 18 years of age on the day of signing informed consent&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2&#xD;
  &#xD;
            -  Histologically confirmed well-differentiated gastrointestinal or pancreatic&#xD;
               neuroendocrine tumor that is grade 1 or grade 2 (Ki-67 =&lt; 20%)&#xD;
  &#xD;
            -  Somatostatin receptor avidity of known or suspected neuroendocrine tumor (NET)&#xD;
               lesion(s) assessed by a baseline copper-64 dotatate PET/CT scan performed within 6&#xD;
               months (180 days) prior to surgical debulking on study day 0. The somatostatin&#xD;
               receptor avidity of the majority of suspected NET lesion(s) must be &gt;= normal liver&#xD;
               uptake&#xD;
  &#xD;
            -  Patient must have hepatic metastasis or hepatic metastases. Provided required hepatic&#xD;
               metastatic disease is present, patient can also have any other site or sites of&#xD;
               metastatic disease&#xD;
  &#xD;
            -  White blood cell count (WBC) &gt;= 2000/uL (resulted =&lt; 90 days prior to surgical&#xD;
               debulking on day 0 of participation in this study)&#xD;
  &#xD;
            -  Platelets &gt;= 75,000/uL (resulted =&lt; 90 days prior to surgical debulking on day 0 of&#xD;
               participation in this study)&#xD;
  &#xD;
            -  Hemoglobin &gt;= 8.0 g/dL (resulted =&lt; 90 days prior to surgical debulking on day 0 of&#xD;
               participation in this study)&#xD;
  &#xD;
            -  Creatinine clearance (CrCl) &gt;= 30 mL/minute (as calculated by the Cockcroft-Gault&#xD;
               Formula with estimated creatinine clearance rate [eCCR] &gt;= 30 mL/min required for&#xD;
               eligibility inclusion; or calculated/measured by an alternative established&#xD;
               institutional standard consistently applied across participants at the site) (resulted&#xD;
               =&lt; 90 days prior to surgical debulking on day 0 of participation in this study)&#xD;
  &#xD;
            -  Total bilirubin =&lt; 3.0 times institutional upper limit of normal (ULN) (resulted =&lt; 90&#xD;
               days prior to surgical debulking on day 0 of participation in this study)&#xD;
  &#xD;
            -  Serum albumin &gt;= 3.0 g/dL unless the prothrombin time is within normal range (resulted&#xD;
               =&lt; 90 days prior to surgical debulking on day 0 of participation in this study)&#xD;
  &#xD;
            -  Women must not be breastfeeding and further agree to not breastfeed during treatment&#xD;
               with lutetium Lu 177 dotatate; and for at least 2.5 months after patient's final dose&#xD;
               of lutetium Lu 177 dotatate&#xD;
  &#xD;
            -  A woman of childbearing potential (WOCBP) - must have a negative serum or urine&#xD;
               pregnancy test resulted within 28 days prior to initiation of first dose of lutetium&#xD;
               Lu 177 dotatate on cycle 1, day 1; and must agree to follow instructions for using&#xD;
               acceptable contraception from the time of signing consent, and until 7 months after&#xD;
               her final dose of lutetium Lu 177 dotatate&#xD;
  &#xD;
            -  A man able to father children who is sexually active with a WOCBP must agree to follow&#xD;
               instructions for using acceptable contraception, from the time of signing consent, and&#xD;
               until 4 months after his final dose of lutetium Lu 177 dotatate&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient has any tumor &gt; 3 cm deemed to be inoperable&#xD;
  &#xD;
            -  Patient has disease which is considered to be completely surgically resectable&#xD;
  &#xD;
            -  Patient has grade 3 neuroendocrine neoplasm (well-differentiated or&#xD;
               poorly-differentiated tumor)&#xD;
  &#xD;
            -  Prior receipt of peptide receptor radionuclide therapy (PRRT)&#xD;
  &#xD;
            -  Patient possesses untreated or growing brain metastases (growth within 90 days prior&#xD;
               to surgical debulking on day 0 of participation in this study)&#xD;
  &#xD;
            -  Unstable angina, congestive heart failure with New York Heart Association (NYHA)&#xD;
               functional classification III or IV, or uncontrolled symptomatic cardiac arrythmia&#xD;
  &#xD;
            -  Any other significant medical, psychiatric, or surgical condition, currently&#xD;
               uncontrolled by treatment, which in the judgment of the patient's study physician may&#xD;
               reasonably be expected to interfere with patient's completion of the study&#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>Kamran Idrees, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Vanderbilt University/Ingram Cancer Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Vanderbilt-Ingram Services for Timely Access</last_name>
      <phone>800-811-8480</phone>
      <email>cip@vumc.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>Vanderbilt University/Ingram Cancer Center</name>
        <address>
          <city>Nashville</city>
          <state>Tennessee</state>
          <zip>37203</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Vanderbilt-Ingram Service for Timely Access</last_name>
        <phone>800-811-8480</phone>
        <email>cip@vumc.org</email>
      </contact>
      <investigator>
        <last_name>Kamran Idrees, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Vanderbilt-Ingram Cancer Center</investigator_affiliation>
      <investigator_full_name>Kamran Idrees</investigator_full_name>
      <investigator_title>Associate Professor of Surgery</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
      <mesh_term>Neuroendocrine Tumors</mesh_term>
      <mesh_term>Adenoma, Islet Cell</mesh_term>
      <mesh_term>Intestinal Neoplasms</mesh_term>
      <mesh_term>Pancreatic Neoplasms</mesh_term>
      <mesh_term>Stomach Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Copper</mesh_term>
      <mesh_term>Lutetium Lu 177 dotatate</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06016855
  org study id: VICCGI2283
  secondary id: NCI-2023-05914
  nct id: NCT06016855
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  This phase IV trial evaluates how well giving standard of care (SOC) peptide receptor
        radionuclide therapy (PRRT) after SOC surgical removal of as much tumor as possible
        (debulking surgery) works in treating patients with grade 1 or 2, somatostatin receptor
        (SSTR) positive, gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have spread
        from where they first started (primary site) to the liver (hepatic metastasis). Lutetium Lu
        177 dotatate is a radioactive drug that uses targeted radiation to kill tumor cells. Lutetium
        Lu 177 dotatate includes a radioactive form (an isotope) of the element called lutetium. This
        radioactive isotope (Lu-177) is attached to a molecule called dotatate. On the surface of
        GEP-NET tumor cells, a receptor called a somatostatin receptor binds to dotatate. When this
        binding occurs, the lutetium Lu 177 dotatate drug then enters somatostatin receptor-positive
        tumor cells, and radiation emitted by Lu-177 helps kill the cells. Giving lutetium Lu 177
        dotatate after surgical debulking may better treat patients with grade 1/2 GEP-NETs
  PRIMARY OBJECTIVES:
  
        I. To measure objective response rate of a combination standard of care treatment in
        gastroenteropancreatic neuroendocrine tumors by initiating lutetium Lu 177 dotatate within 90
        days of surgical debulking.
  
        II. To assess the radiomic profile including somatostatin receptor standardized uptake values
        (SSTR SUV) of large and non-large tumors in study patients)
  
        III: To assess the safety and tolerability of peptide receptor radionuclide therapy (PRRT)
        post-surgical debulking in patients on study.
  
        IV. To assess the tumor genomic profile of large, resected tumors from patients and assess
        for signatures of radioresistance.
  
        OUTLINE:
  
        Patients undergo surgical debulking on day 0 and receive lutetium Lu 177 dotatate (177Lu
        dotatate) intravenously (IV) over 30 to 40 minutes on day 1 of each cycle. Treatment repeats
        every 56 days for up to 4 cycles in the absence of disease progression or unacceptable
        toxicity. Patients undergo computed tomography (CT) scan or magnetic resonance imaging (MRI)
        throughout the trial, and undergo copper Cu 64 dotatate positron emission tomography/CT
        (dotatate PET/CT) during screening and on study.
  
        After completion of study treatment, patients are followed up at 30-37 days after last dose
        and then every 3 months for 2 years.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Somatostatin receptor standardized uptake values (SSTR SUV)
  time frame: Up to 2 years
  description: SSTR SUV (not limited to but including measures such as SSTR SUV max, SSTR SUV mean) will be estimated for the patients undergoing post-operative research dotatate scans and compared to values from peptide receptor radionuclide therapy (PRRT) eligibility-conferring dotatate scans in these same patients. These quantitative analytics will be performed by central review. Changes in SSTR SUV values will be analyzed with summary statistics.
  measure: Progression-free survival
  time frame: From the start of PRRT to the date the patient progresses radiographically or succumbs to the disease, assessed up to 2 years
  description: Will be estimated by the Kaplan-Meier method.
  measure: Overall response rate
  time frame: Up to 2 years
  description: Will be estimated by measuring the number of patients who achieve a complete response or partial response by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria on restaging computed tomography or magnetic resonance imaging scans =< 6 months from PRRT completion, from the total number of patients who received the study treatment and possessed measurable disease post-surgical debulking. The number of patients who possessed measurable disease which did not meet RECIST 1.1 eligibility criteria post-surgical debulking will also be recorded.
  measure: Overall survival
  time frame: From the start of PRRT to the date the patient progresses radiographically or succumbs to the disease, assessed up to 2 years
  description: Will be estimated by the Kaplan-Meier method.
  measure: Incidence of adverse events
  time frame: Up to 2 years
  description: Toxicity will be estimated by documenting the grade 3/4 adverse events, according to Common Terminology Criteria for Adverse Events version 5.0, experienced by study patients.
  measure: Gene mutations
  time frame: Up to 2 years
  description: Mutations in genes associated with radioresistance (defined from other malignancies) and other mutations in large resected neuroendocrine tumors will be recorded. Mutations will be described descriptively.
  arm group label: Treatment (surgical debulking, 177Lu dotatate)
  arm group type: Experimental
  description: Patients undergo surgical debulking on day 0 and receive 177Lu dotatate IV over 30 to 40 minutes on day 1 of each cycle. Treatment repeats every 56 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI throughout the trial, and undergo dotatate PET/CT during screening and on study.
  intervention type: Procedure
  intervention name: Tumor Debulking
  description: Undergo surgical debulking
  arm group label: Treatment (surgical debulking, 177Lu dotatate)
  intervention type: Drug
  intervention name: Lutetium Lu 177 Dotatate
  description: Given by IV
  arm group label: Treatment (surgical debulking, 177Lu dotatate)
  intervention type: Procedure
  intervention name: Computed Tomography
  description: Undergo Computed Tomography
  arm group label: Treatment (surgical debulking, 177Lu dotatate)
  intervention type: Procedure
  intervention name: Magnetic Resonance Imaging
  description: Undergo Magnetic Resonance Imaging
  arm group label: Treatment (surgical debulking, 177Lu dotatate)
  intervention type: Drug
  intervention name: Copper Cu 64 Dotatate
  description: Given by IV
  arm group label: Treatment (surgical debulking, 177Lu dotatate)
  intervention type: Procedure
  intervention name: Positron Emission Tomography
  description: Undergo Positron Emission Tomography
  arm group label: Treatment (surgical debulking, 177Lu dotatate)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Kamran Idrees, MD
  role: Principal Investigator
  affiliation: Vanderbilt University/Ingram Cancer Center
  last name: Vanderbilt-Ingram Services for Timely Access
  phone: 800-811-8480
  email: cip@vumc.org
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Vanderbilt-Ingram Cancer Center
  investigator full name: Kamran Idrees
  investigator title: Associate Professor of Surgery
  mesh term: Neoplasms
  mesh term: Neuroendocrine Tumors
  mesh term: Adenoma, Islet Cell
  mesh term: Intestinal Neoplasms
  mesh term: Pancreatic Neoplasms
  mesh term: Stomach Neoplasms
  mesh term: Copper
  mesh term: Lutetium Lu 177 dotatate