Clinical trial NCT03583528: DOTATOC PET/CT for Imaging NET Patients
Official title: Evaluation of the Safety and Sensitivity of 68Ga-DOTATOC PET/CT for Imaging NET Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
First posted: 2018-07-11
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This will be a prospective, open-label trial in patients with suspected or proven SSTR positive tumors.

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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Sensitivity of 68Ga-DOTATOC PET/CT in the diagnosis of SSTR positive tumors.
timeFrame: 3 years
Secondary outcomes:
measure: Number of participants with 68Ga-DOTATOC-related adverse events as assessed by abnormal vital sign measurement.
timeFrame: 1 hour
measure: Number of participants with self-reported 68Ga-DOTATOC-related adverse event
timeFrame: 24 hours
measure: Total number of lesions per anatomic location identified by 68Ga-DOTATOC PET/CT
timeFrame: 3 years
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Cancer
state: British Columbia
Study officials:
affiliation: BC Cancer
name: Francois Benard, MD
role: PRINCIPAL_INVESTIGATOR
References: