A Study to Evaluate a New Way to Identify/Diagnose Tumours With Somatostatin Receptors Using [68]Ga-HA-DOTATATE and to Ensure it is Safe to Use

NCT ID: NCT03145857

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 1534 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-05
• Study Completion Date: 2046-08-31

Brief Summary

A [68]Ga-HA-DOTATATE PET/CT or PET/MRI scan is a nuclear medicine test used to create pictures of the whole body that will show where somatostatin receptors are found, including on tumours. Somatostatin receptors are found on most neuroendocrine tumours (NETs), and some other types of tumours. Currently at the Cross Cancer Institute, most patients with suspected somatostatin positive tumours (e.g. NETs) have an In-111 Octreotide (Octreoscan™) scan. A scientific study has shown that a scan with a similar product ([68]Ga-DOTATATE) is more accurate than an Octreoscan™. This study will look at [68]Ga-HA-DOTATATE, a product virtually identical to [68]Ga-DOTATATE.

The purpose of this study is to: 1) demonstrate the safety of [68]Ga-HA-DOTATATE; and 2) confirm that [68]Ga-HA-DOTATATE PET/CT or PET/MRI is effective at diagnosing somatostatin positive tumours.

Detailed Description

The proposed clinical trial will be a sequential Phase I/II, diagnostic imaging, controlled, open label, single site study in a broad cross-section of patients with known or suspected somatostatin receptor positive tumours. All participants will be imaged with [68]Ga-HA-DOTATATE PET/CT or PET/MRI for uptake by somatostatin receptor positive tumours. Up to seven [68]Ga-HA-DOTATATE scans may be performed per participant, as clinically indicated. A safety evaluation will be conducted on the first 10 consecutively enrolled participants (safety sub-group), consisting of vital signs, haematology and serum biochemistry profile (pre-injection and post-imaging), and an adverse event (AE) assessment (up to 24 hours) after [68]Ga-HA-DOTATATE imaging. The safety evaluation for subsequent [68]Ga-HA-DOTATATE scan visits for participants in the safety sub-group and for the remaining participants will consist of an AE assessment while in the Nuclear Medicine department. The efficacy evaluation will include [68]Ga-HA-DOTATATE scan clinical accuracy compared to standard of care CT.

Conditions

Neuroendocrine Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

[68]Ga-HA-DOTATATE

All participants will be imaged with \[68\]Ga-HA-DOTATATE PET/CT or PET/MRI for uptake by somatostatin receptor positive tumours. Up to seven \[68\]Ga-HA-DOTATATE scans may be performed per participant, as clinically indicated.

Group Type: EXPERIMENTAL

[68]Ga-HA-DOTATATE

Intervention Type: DRUG

All participants will be injected with \[68\]Ga-HA-DOTATATE approximately 60 minutes before PET/CT or PET/MRI scan.

Interventions

[68]Ga-HA-DOTATATE

All participants will be injected with \[68\]Ga-HA-DOTATATE approximately 60 minutes before PET/CT or PET/MRI scan.

Intervention Type: DRUG

Other Intervention Names

Gallium-68 high affinity-DOTATATE; Gallium-68 DOTA-3-iodo-Tyr(3)-octreotate

Eligibility Criteria

Inclusion Criteria

1. Known or suspected somatostatin receptor positive tumour including, but not limited to, GNET, PNET, pulmonary NET, PRUNK NET, pheochromocytoma, paraganglioma, medullary thyroid cancer, and medulloblastoma. A standard CT obtained within 6 months of enrolment is required. A standard MRI obtained within 6 months of enrolment is optional. Additional supporting evidence obtained within 12 months of enrolment may include: other standard imaging (In-111 octreotide (Octreoscan), [18]F-FDG PET, or [18]F-FDOPA PET); histopathology from surgery or biopsy; elevated biochemical markers (including Chromogranin A, 5-HIAA, insulin, vasoactive intestinal peptide (VIP), glucagon, gastrin, metanephrines, and/or others, as clinically indicated); and/or persistent carcinoid-like symptomology highly suspicious for the presence of NET even in absence of pathologic imaging findings by anatomic criteria;

2. Eastern Cooperative Oncology Group (ECOG) Performance Scale Score ≤ 3 within 2 weeks of enrolment;

3. At least 14 years of age;

4. Able and willing to follow instructions and comply with the protocol;

5. Ability to provide written informed consent prior to participation in the study.

Exclusion Criteria

1. Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.);

2. Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.);

3. Any additional medical condition, serious inter-current illness or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study performance or interpretation;

4. Weight exceeding the PET/CT or PET/MR scanner limit;

5. Pregnancy;

6. Allergic reaction to DOTATATE or somatostatin analogues.

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AHS Cancer Control Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Todd PW McMullen, MD, PhD, FRCSC, FACS

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of Surgery and Oncology; Director, Division of Surgical Oncology, Department of Oncology

Locations

Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

NET Coordinator

Role: CONTACT

ACB.NeuroEndocrine@ahs.ca

780-577-8080

Other Identifiers

HREBA.CC-16-1013

Identifier Type: OTHER

Identifier Source: secondary_id

DX-GAL-001

Identifier Type: -

Identifier Source: org_study_id