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Active, Not Recruiting

NCT Number: NCT03583528

DOTATOC PET/CT for Imaging NET Patients

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Neuroendocrine Tumors Adenocarcinoma Adenoma Adenoma, Islet Cell Brain Diseases Brain Neoplasms Bronchial Neoplasms Carcinoid Carcinoid Tumor Carcinoma Carcinoma, Bronchogenic Carcinoma, Islet Cell Carcinoma, Medullary Carcinoma, Merkel Cell Carcinoma, Neuroendocrine Central Nervous System Diseases Central Nervous System Neoplasms DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Ganglioneuroma Gastrinoma Glioma Glucagonoma Hypothalamic Diseases Hypothalamic Neoplasms Infections Insulinoma Lung Diseases Lung Neoplasms Medullary Carcinoma Medulloblastoma Meningeal Neoplasms Meningioma Merkel Cell Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplasms, Vascular Tissue Nervous System Diseases Nervous System Neoplasms Neuroblastoma Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Pancreatic Diseases Pancreatic Neoplasms Paraganglioma Pheochromocytoma Pituitary Adenoma Pituitary Diseases Pituitary Neoplasms Polyomavirus Infections Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Small-cell Lung Cancer Supratentorial Neoplasms Thoracic Neoplasms Tumor Virus Infections Vipoma Virus Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

BC Cancer

Vancouver, British Columbia, V5Z 4E6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 3 years

    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.

Secondary outcomes

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

    Time frame: 1 hour

    Vital signs (blood pressure, heart rate and pulse oximetry) will be measured at three time points (before and after injection, and 1 hour after the injection). All values that fall outside of the normal parameters will be assessed by a physician and reported as an adverse event.

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

    Time frame: 24 hours

    Patients will be contacted by phone 24 hours after the 68Ga-DOTATOC PET/CT scan to see if they experienced any adverse events. These are recorded and evaluated for severity and likelihood they are related to the study drug. All adverse events will be recorded and summarized in the final report.

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

    Time frame: 3 years

    All lesions will be tabulated and classified by compartment (pancreas, liver, bowel, lung and mediastinum, abdomen and retroperitoneal lymph nodes, bone, other) for all imaging modalities that have been done for that subject. A total number of lesions (for all modalities) will be calculated and a proportion of lesions detected by each modality will be reported and will be compared by calculating the median and its confidence interval. This will assess the efficacy of 68Ga-DOTATOC PET/CT.

Sponsors and collaborators

Lead sponsor

British Columbia Cancer Agency

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2026
Study completion
2028
First posted
Jul 11, 2018
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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