DOTATOC PET/CT for Imaging NET Patients

NCT03583528 | Active Not Recruiting

• 1 other identifier: H17-00909
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  Determination of sensitivity of both exams when compared with pathology reports (if available) and compared with routine imaging (CT, MRI, Octreoscan™, US) if available and will be determined by confidence intervals using an exact binominal distribution by comparing the 68Ga-DOTATOC PET/CT with 18F-FDG and conventional imaging (if available). The gold standard for the detection of lesions will be established through a combination of: 1) pathology; 2) unequivocal correlative imaging results as assessed independently by 2 physicians; 3) disease progression of specific findings upon follow-up, up to three years from baseline examination; 4) a clearly unequivocal plurimetastatic pattern confirmed by any imaging modality at any of the involved sites; 5) response of lesions on subsequent imaging following therapy.

  3 years

Secondary Outcomes (3)

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

  1 hour

• Number of participants with self-reported 68Ga-DOTATOC-related adverse event

  24 hours

• Total number of lesions per anatomic location identified by 68Ga-DOTATOC PET/CT

  3 years

Study Arms (1)

PET/CT Diagnostic Imaging

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.

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

Interventions

68Ga-DOTATOC PET/CT DIAGNOSTIC_TEST

Blood pressure, heart rate, and oxygen saturation levels will be recorded prior to the injection and at 5 - 15 minutes after injection. Each study subject will have an intravenous catheter inserted. The subject will receive a bolus intravenous dose of the radiotracer from an approved study supplier site. The subject will rest in a comfortable chair for 60 minutes. After this uptake phase, the blood pressure, heart rate, and oxygen saturation levels will be recorded again. The subjects will then be taken to a designated washroom and asked to void prior to being scanned in order to clear excreted radiotracer activity from the urinary tract. Subjects are positioned supine, arms down, and centered on the scanner bed and the PET/CT images will be acquired.

PET/CT Diagnostic Imaging

18F-FDG PET/CT DIAGNOSTIC_TEST

18F-FDG PET/CT For 18F-FDG as fasting period of 6 hours is required before the scan. Each study subject will have an intravenous catheter inserted. The subject will receive a bolus intravenous dose of the radiotracer from an approved study supplier site. The subject will rest in a comfortable chair for 60 minutes. The subjects will then be taken to a designated washroom and asked to void prior to being scanned in order to clear excreted radiotracer activity from the urinary tract. Subjects are positioned supine, arms down, and centered on the scanner bed and the PET/CT images will be acquired.

PET/CT Diagnostic Imaging

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This will be a prospective, open-label trial in patients with suspected or proven SSTR positive tumors.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (1)

BC Cancer

Vancouver, British Columbia, V5Z 4E6, Canada

Location

MeSH Terms

Conditions

Neuroendocrine Tumors; Insulinoma; Gastrinoma; Glucagonoma; Vipoma; Pheochromocytoma; Paraganglioma; Neuroblastoma; Ganglioneuroma; Carcinoma, Medullary; Pituitary Neoplasms; Medulloblastoma; Carcinoma, Merkel Cell; Small Cell Lung Carcinoma; Meningioma; Carcinoid Tumor

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Adenoma, Islet Cell; Adenoma; Neoplasms, Glandular and Epithelial; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Carcinoma, Islet Cell; Adenocarcinoma; Carcinoma; Carcinoma, Neuroendocrine; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neoplasms, Ductal, Lobular, and Medullary; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Glioma; Polyomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasms, Vascular Tissue; Meningeal Neoplasms

Study Officials

• Francois Benard, MD

  BC Cancer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2018
• First Posted: July 11, 2018
• Study Start: July 11, 2018
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 30, 2028
• Last Updated: June 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)