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

NCT03145857 | Recruiting Phase 1 DMC

• 2 other identifiers: DX-GAL-001HREBA.CC-16-1013
• Study Type: interventional
• Target: 1,534
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroendocrine Tumors

Keywords

Gallium-68; Positron Emission Tomography; 68Ga-HA-DOTATATE

Outcome Measures

Primary Outcomes (5)

• Change in vital signs after first [68]Ga-HA-DOTATATE injection (safety sub-group)

  Vital signs are measured before first injection of \[68\]Ga-HA-DOTATATE and after \[68\]Ga-HA-DOTATATE scan and changes will be summarized.

  Before first [68]Ga-HA-DOTATATE injection and after [68]Ga-HA-DOTATATE scan (within ~30 min)

• Changes in haematology and biochemistry after first [68]Ga-HA-DOTATATE injection (safety sub-group)

  A blood sample is drawn before first injection of \[68\]Ga-HA-DOTATATE and after \[68\]Ga-HA-DOTATATE scan. The haematology and biochemistry parameters will be recorded and all changes will be summarized.

  Before first [68]Ga-HA-DOTATATE injection and after [68]Ga-HA-DOTATATE scan (within ~30 min)

• Number of participants with adverse events within 24 hours (safety sub-group)

  Participants will be evaluated for AE occurrence once the \[68\]Ga-HA-DOTATATE has been administered for AEs occuring within 24 h of first scan.

  Within 24 hours of [68]Ga-HA-DOTATATE scan completion

• Number of participants with adverse events

  Participants will be evaluated for AE occurrence once the \[68\]Ga-HA-DOTATATE has been administered for AEs occuring while in the Nuclear Medicine Department.

  Up to 2 hours after [68]Ga-HA-DOTATATE administration

• Correlation of [68]Ga-HA-DOTATATE scan diagnostic effectiveness with standard of care CT

  \[68\]Ga-HA-DOTATATE scans will be evaluated for abnormal accumulation of \[68\]Ga-HA-DOTATATE. The maximum Standardized Uptake Value (SUVmax) will be determined for up to 5 lesions and compared to results of baseline standard of care CT for presence/absence of each lesion. An overall assessment of the correlation between \[68\]Ga-HA-DOTATATE PET/CT or PET/MRI and baseline CT will be made.

  Up to 6 years

Secondary Outcomes (2)

• Evaluation of [68]Ga-HA-DOTATATE scan changes compared to baseline scan

  Up to 6 years

• Correlation of [68]Ga-HA-DOTATATE scan diagnostic effectiveness with standard of care MRI

  Up to 6 years

Study Arms (1)

[68]Ga-HA-DOTATATE

EXPERIMENTAL

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.

Drug: [68]Ga-HA-DOTATATE

Interventions

[68]Ga-HA-DOTATATE DRUG

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

Also known as: Gallium-68 high affinity-DOTATATE, Gallium-68 DOTA-3-iodo-Tyr(3)-octreotate

[68]Ga-HA-DOTATATE

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Eastern Cooperative Oncology Group (ECOG) Performance Scale Score ≤ 3 within 2 weeks of enrolment;
• At least 14 years of age;
• Able and willing to follow instructions and comply with the protocol;
• Ability to provide written informed consent prior to participation in the study.

You may not qualify if:

• Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.);
• Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.);
• 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;
• Weight exceeding the PET/CT or PET/MR scanner limit;
• Pregnancy;
• Allergic reaction to DOTATATE or somatostatin analogues.

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

RECRUITING

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Todd PW McMullen, MD, PhD, FRCSC, FACS

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

NET Coordinator

CONTACT

780-577-8080; ACB.NeuroEndocrine@ahs.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 9, 2017
• Study Start: March 5, 2020
• Primary Completion (Estimated): August 1, 2040
• Study Completion (Estimated): August 1, 2046
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)