DOTATOC PET/CT for Imaging NET Patients

British Columbia Cancer Agency

Status: Active, not recruiting

Conditions: Glucagonoma; Small-cell Lung Cancer; Neuroblastoma; Medullary Carcinoma; Medulloblastoma; Neuroendocrine Tumors; Vipoma; Gastrinoma; Merkel Cell Carcinoma; Insulinoma; Meningioma; Paraganglioma; Pituitary Adenoma; Carcinoid; Ganglioneuroma; Pheochromocytoma

Treatments: Diagnostic Test: 68Ga-DOTATOC PET/CT; Diagnostic Test: 18F-FDG PET/CT

Study type: Observational

Funder types: Other

Identifiers

NCT03583528

H17-00909

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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).

Trial design

800 participants in 1 patient group

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.

Treatment:

Diagnostic Test: 18F-FDG PET/CT

Diagnostic Test: 68Ga-DOTATOC PET/CT