DOTATOC PET/CT for Imaging NET Patients

Brief Title

DOTATOC PET/CT for Imaging NET Patients

Official Title

Evaluation of the Safety and Sensitivity of 68Ga-DOTATOC PET/CT for Imaging NET Patients

Brief Summary

      Neuroendocrine tumours (NETs) are generally slow growing, but some can be aggressive and
      resistant to treatment. Compared to healthy cells, the surface of these tumor cells has a
      greater number of special molecules called somatostatin receptors (SSTR). Somatostatin
      receptor scintigraphy and conventional imaging are used to detect NETs.

      This study proposes 68Gallium(68Ga)-DOTATOC positron emission tomography/computed tomography
      (PET/CT) is superior to current imaging techniques. The goal is to evaluate the safety and
      sensitivity of 68Ga-DOTATOC PET/CT at detecting NETs and other tumors with over-expression of
      somatostatin receptors.
    

Detailed Description

      Each subject will have two PET/CT scans, one using 68Ga-DOTATOC and the other using
      18-Fluoride-Fluorodeoxyglucose (18F-FDG). The 68Ga-DOTATOC radioactive tracer is manufactured
      for this study under a Clinical Trial Application filed with Health Canada. 18F-FDG is
      considered standard care and has been approved by Health Canada.

      After providing informed written consent subjects will complete a medical history
      questionnaire.

      Monitoring of adverse events There will be short-term evaluation of adverse events by
      comparison of vital signs before and after administration of 68Ga-DOTATOC. Twenty-four hours
      after 68Ga-DOTATOC administration the study coordinator will call the patient and see if they
      have experienced any adverse events during that time period and complete the adverse event
      questionnaire found in section 9.6.

      Follow-up Assessments

      The following information will be collected up to 3 years following the PET/CT scans:

        -  Initiation of a new treatment

        -  Laboratory results and pathology reports

        -  Results of imaging studies

        -  Final clinical diagnosis by physician and relevant clinical notes

      The study is expected to take approximately 4 years for accrual.
    

Study Type

Observational

Primary Outcome

Sensitivity of 68Ga-DOTATOC PET/CT in the diagnosis of SSTR positive tumors.

Secondary Outcome

 Number of participants with 68Ga-DOTATOC-related adverse events as assessed by abnormal vital sign measurement.

Condition

Neuroendocrine Tumors

Intervention

68Ga-DOTATOC PET/CT

Study Arms / Comparison Groups

 PET/CT Diagnostic Imaging

Description:  Each subject will have two PET/CT scans, one using 68Ga-DOTATOC and the other using 18F-FDG. The 68Ga-DOTATOC radioactive tracer is manufactured for this study under a Clinical Trial Application filed with Health Canada. 18F-FDG is considered standard care and has been approved by Health Canada.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Diagnostic Test

Estimated Enrollment

400

Start Date

July 11, 2018

Completion Date

December 31, 2026

Primary Completion Date

December 31, 2023

Eligibility Criteria

        Inclusion Criteria:

        All subjects:

          -  World health organization performance status 0-2

          -  Able to provide written informed consent/assent (or consent by guardian for subjects
             <19 years)

          -  Patients must be able to tolerate the physical/logistical requirements of completing a
             PET scan including lying flat for up to 30 minutes and tolerating intravenous
             cannulation for injection.

        Patients must require imaging for either staging or re-staging of:

          -  Gastroenteropancreatic tumors (e.g. carcinoids, gastrinoma, insulinoma, glucagonoma,
             VIPoma, etc.), functioning and non-functioning

          -  Sympathoadrenal system tumors (phaeochromocytoma, paraganglioma, neuroblastoma,
             ganglioneuroma)

          -  Medullary thyroid carcinoma

          -  Pituitary adenoma

          -  Medulloblastoma

          -  Merkel cell carcinoma

          -  Small-cell lung cancer (mainly primary tumors)

          -  Meningioma

          -  Or any other NET / with potential for overexpression of SSTR

        Exclusion Criteria:

          -  Pregnancy

          -  Patients who are medically unstable ex: acute cardiac or respiratory distress,
             hypotensive

          -  Patients who exceed the safe weight limit of the PET/CT bed (204.5 kg) or who cannot
             fit through the PET/CT bore (diameter 70cm).
      

Gender

All

Ages

18 Years - 100 Years

Accepts Healthy Volunteers

No

Contacts

Francois Benard, MD, 604-877-6000, [email protected]

Location Countries

Canada

Location Countries

Canada

NCT ID

NCT03583528

Organization ID

H17-00909

Responsible Party

Sponsor

Study Sponsor

British Columbia Cancer Agency

Study Sponsor

Francois Benard, MD, Principal Investigator, BC Cancer

Verification Date

January 2021