DOTATOC PET/CT for Imaging NET Patients

Official Title

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

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 tumour 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 tumours with over-expression of somatostatin receptors.

Trial Description

Primary Outcome:

  • Sensitivity of 68Ga-DOTATOC PET/CT in the diagnosis of SSTR positive tumours.
Secondary Outcome:
  • Number of participants with 68Ga-DOTATOC-related adverse events as assessed by abnormal vital sign measurement.
  • Number of participants with self-reported 68Ga-DOTATOC-related adverse event
  • Total number of lesions per anatomic location identified by 68Ga-DOTATOC PET/CT
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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society