DOTATOC PET/CT for Imaging NET Patients

  • STATUS
    Recruiting
  • End date
    Dec 31, 2026
  • participants needed
    400
  • sponsor
    British Columbia Cancer Agency
Updated on 24 March 2022
ct scan
cancer
pituitary
meningioma
carcinoma
fasting
somatostatin
adenoma
lung cancer
tumor cells
primary tumor
positron emission tomography
18f-fdg
conventional imaging
paraganglioma
dotatate
pheochromocytoma
pet/ct scan
medulloblastoma
fdg pet
positron emission tomography/computed tomography
neuroendocrine tumor
dotatoc
medullary thyroid carcinoma
thyroid carcinoma
octreotide scan
carcinoid
fdg pet/ct
pet-ct scan
carcinoid tumor
pituitary adenoma
neuroendocrine tumour
vipoma
somatostatin receptor scintigraphy
68ga-dotatoc
edotreotide
adrenal pheochromocytoma
phaeochromocytoma
merkel cell carcinoma

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.

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.

Details
Condition Neuroendocrine Tumors, Insulinoma, Gastrinoma, Glucagonoma, Vipoma, Pheochromocytoma, Paraganglioma, Neuroblastoma, Ganglioneuroma, Medullary Carcinoma, Pituitary Adenoma, Medulloblastoma, Merkel Cell Carcinoma, Small-cell Lung Cancer, Meningioma, Carcinoid
Treatment 68Ga-DOTATOC PET/CT, 18F-FDG PET/CT
Clinical Study IdentifierNCT03583528
SponsorBritish Columbia Cancer Agency
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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