<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/NCT03284775</url>
  </required_header>
  <id_info>
    <org_study_id>17/0310</org_study_id>
    <nct_id>NCT03284775</nct_id>
  </id_info>
  <brief_title>Intraoperative Ultrasound in Patients Undergoing Transsphenoidal Surgery for Pituitary Adenoma</brief_title>
  <official_title>Intraoperative Ultrasound in Patients Undergoing Transsphenoidal Surgery for Pituitary Adenoma: a Prospective Devleopment Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University College, London</source>
  <oversight_info>
    <has_dmc>No</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>
      Pituitary adenoma can be difficult to cure with approximately a third of patients in&#xD;
      contemporary series' undergoing incomplete resection. Over the last decade or so a handful of&#xD;
      groups have described the use intraoperative ultrasound to improve resection. Although&#xD;
      limited, these proof-of-concept studies suggest intraoperative ultrasound is a safe and&#xD;
      effective technological adjunct to transsphenoidal surgery for pituitary adenoma.&#xD;
&#xD;
      In this prospective development study 30 adult patients will undergo transsphenoidal surgery&#xD;
      for pituitary adenoma with prototype intraoperative ultrasound devices. The primary outcomes&#xD;
      will be technical feasibility and device safety. The secondary outcomes will be complete&#xD;
      versus incomplete radiological resection, endocrinological remission, the occurrence of&#xD;
      postoperative complications, operating time, and length of stay.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 7, 2019</start_date>
  <completion_date type="Anticipated">August 2023</completion_date>
  <primary_completion_date type="Actual">August 3, 2022</primary_completion_date>
  <phase>N/A</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>Technical feasibility</measure>
    <time_frame>Intraoperative</time_frame>
    <description>Technical feasibility will be assessed by the capacity of our system to provide ultrasound images of pituitary and adenoma tissue that correspond to pre- and post-operative MRI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Device safety</measure>
    <time_frame>Intraoperative</time_frame>
    <description>Device safety will be assessed by the number, type, and severity of adverse events related to use of the device e.g., device malfunction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Radiological resection</measure>
    <time_frame>Early post-operative</time_frame>
    <description>Radiological resection will be determined by a radiologist as gross total resection (GTR), subtotal resection (STR) when more than 80% of the tumour is resected, and partial resection when less than 80% of the tumour is resected.10 Residual tumour will be classified according to its location as intrasellar, suprasellar, intracavernous, or combined.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endocrinological remission</measure>
    <time_frame>Early post-operative</time_frame>
    <description>Endocrinological remission will be determined by an endocrinologist. The criteria for acromegaly control will be normalisation of serum insulin-like growth factor and suppression of the nadir serum growth hormone level after oral glucose tolerance test. The criteria for Cushing's disease control will be normalisation of early morning serum cortisol and suppression of serum cortisol after low dose dexamethasone suppression test. The criteria for prolactinoma control will be normalisation of serum prolactin.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative complications</measure>
    <time_frame>Early post-operative</time_frame>
    <description>Postoperative complications will include death, cerebrospinal fluid leak, meningitis, vascular complications, visual complications, diabetes insipidus transient and permanent, hypopituitarism, and cranial nerve injury. Vascular complications will include carotid or other vessel injury, or symptomatic haematoma. Venous bleeding from the cavernous sinus will be considered a vascular complication only if it prevents completion of the surgical procedure. Epistaxis will only be considered a vascular complication if it warrants return to the operating room. Cerebrospinal fluid leaks will include all postoperative leaks, and all patients who develop an intraoperative leak requiring lumbar drainage. Patients with Cushing's disease receiving postoperative cortisol, or in whom a hypophysectomy was carried out will also not be included as surgical complications.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operating time (minutes)</measure>
    <time_frame>Intra-operative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay (days)</measure>
    <time_frame>Early post-operative</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Pituitary Adenoma</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intraoperative ultrasound</intervention_name>
    <description>Patients will undergo transsphenoidal surgery in the usual manner except that an intraoperative ultrasound device will be available for use to better visualise the tumour and surrounding neurovascular structures.</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patients&#xD;
&#xD;
          -  undergoing transsphenoidal surgery&#xD;
&#xD;
          -  diagnosis of pituitary adenoma on pre-operative MRI&#xD;
&#xD;
          -  able to provide consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients less than 18 years of age&#xD;
&#xD;
          -  patients undergoing transcranial surgery&#xD;
&#xD;
          -  diagnosis other than that of pituitary adenoma on pre-operative MRI e.g., meningioma&#xD;
&#xD;
          -  unable to provide consent e.g., mental illness or later withdrawing consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>National Hospital for Neurology and Neurosurgery</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>November 1, 2022</last_update_submitted>
  <last_update_submitted_qc>November 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</mesh_term>
    <mesh_term>Pituitary Neoplasms</mesh_term>
    <mesh_term>Pituitary Diseases</mesh_term>
  </condition_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/NCT03284775
org study id: 17/0310
nct id: NCT03284775
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pituitary adenoma can be difficult to cure with approximately a third of patients in
      contemporary series' undergoing incomplete resection. Over the last decade or so a handful of
      groups have described the use intraoperative ultrasound to improve resection. Although
      limited, these proof-of-concept studies suggest intraoperative ultrasound is a safe and
      effective technological adjunct to transsphenoidal surgery for pituitary adenoma.

      In this prospective development study 30 adult patients will undergo transsphenoidal surgery
      for pituitary adenoma with prototype intraoperative ultrasound devices. The primary outcomes
      will be technical feasibility and device safety. The secondary outcomes will be complete
      versus incomplete radiological resection, endocrinological remission, the occurrence of
      postoperative complications, operating time, and length of stay.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Technical feasibility
time frame: Intraoperative
description: Technical feasibility will be assessed by the capacity of our system to provide ultrasound images of pituitary and adenoma tissue that correspond to pre- and post-operative MRI.
measure: Device safety
time frame: Intraoperative
description: Device safety will be assessed by the number, type, and severity of adverse events related to use of the device e.g., device malfunction.
measure: Radiological resection
time frame: Early post-operative
description: Radiological resection will be determined by a radiologist as gross total resection (GTR), subtotal resection (STR) when more than 80% of the tumour is resected, and partial resection when less than 80% of the tumour is resected.10 Residual tumour will be classified according to its location as intrasellar, suprasellar, intracavernous, or combined.
measure: Endocrinological remission
time frame: Early post-operative
description: Endocrinological remission will be determined by an endocrinologist. The criteria for acromegaly control will be normalisation of serum insulin-like growth factor and suppression of the nadir serum growth hormone level after oral glucose tolerance test. The criteria for Cushing's disease control will be normalisation of early morning serum cortisol and suppression of serum cortisol after low dose dexamethasone suppression test. The criteria for prolactinoma control will be normalisation of serum prolactin.
measure: Postoperative complications
time frame: Early post-operative
description: Postoperative complications will include death, cerebrospinal fluid leak, meningitis, vascular complications, visual complications, diabetes insipidus transient and permanent, hypopituitarism, and cranial nerve injury. Vascular complications will include carotid or other vessel injury, or symptomatic haematoma. Venous bleeding from the cavernous sinus will be considered a vascular complication only if it prevents completion of the surgical procedure. Epistaxis will only be considered a vascular complication if it warrants return to the operating room. Cerebrospinal fluid leaks will include all postoperative leaks, and all patients who develop an intraoperative leak requiring lumbar drainage. Patients with Cushing's disease receiving postoperative cortisol, or in whom a hypophysectomy was carried out will also not be included as surgical complications.
measure: Operating time (minutes)
time frame: Intra-operative
measure: Length of stay (days)
time frame: Early post-operative
intervention type: Device
intervention name: Intraoperative ultrasound
description: Patients will undergo transsphenoidal surgery in the usual manner except that an intraoperative ultrasound device will be available for use to better visualise the tumour and surrounding neurovascular structures.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Adenoma
mesh term: Pituitary Neoplasms
mesh term: Pituitary Diseases
sharing ipd: No