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[68]Ga-HA-DOTATATE Imaging for Neuroendocrine Tumors

Phase 1 & 2

Recruiting

Led By Todd PW McMullen, MD, PhD, FRCSC, FACS

Research Sponsored by AHS Cancer Control Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 14 years of age

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years

Awards & highlights

Study Summary

This trial will compare the [68]Ga-HA-DOTATATE PET/CT or PET/MRI scan to an Octreoscan™ in patients with known or suspected NETs.

Who is the study for?

This trial is for individuals at least 14 years old with suspected or known tumors that have somatostatin receptors, such as various types of neuroendocrine tumors. Participants must be able to follow the study's protocol and have an ECOG score ≤ 3, indicating they are capable of self-care. They cannot join if they exceed the weight limit for PET scans, are pregnant, allergic to DOTATATE/somatostatin analogues, or unable to remain still during imaging.Check my eligibility

What is being tested?

[68]Ga-HA-DOTATATE is being tested in this trial. It's a new diagnostic agent used in PET/CT or PET/MRI scans to detect somatostatin receptors on tumors more accurately than current methods like Octreoscan™. The study aims to ensure it's safe and effective for identifying these types of tumors.See study design

What are the potential side effects?

While the main focus is on safety and effectiveness rather than side effects, potential risks may include reactions similar to those from other contrast agents used in imaging studies: mild pain or discomfort at injection site, nausea, itching or rash.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 14 years old or older.

Select...

My tumor is suspected to be positive for somatostatin receptors.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

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

+2 more

Secondary outcome measures

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: [68]Ga-HA-DOTATATEExperimental Treatment1 Intervention

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

AHS Cancer Control AlbertaLead Sponsor

182 Previous Clinical Trials

35,712 Total Patients Enrolled

2 Trials studying Neuroendocrine Tumors

207 Patients Enrolled for Neuroendocrine Tumors

Todd PW McMullen, MD, PhD, FRCSC, FACSPrincipal InvestigatorAssociate Professor of Surgery and Oncology; Director, Division of Surgical Oncology, Department of Oncology

Media Library

[68]Ga-HA-DOTATATE Clinical Trial Eligibility Overview. Trial Name: NCT03145857 — Phase 1 & 2

Neuroendocrine Tumors Research Study Groups: [68]Ga-HA-DOTATATE

Neuroendocrine Tumors Clinical Trial 2023: [68]Ga-HA-DOTATATE Highlights & Side Effects. Trial Name: NCT03145857 — Phase 1 & 2

[68]Ga-HA-DOTATATE 2023 Treatment Timeline for Medical Study. Trial Name: NCT03145857 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for individuals to join the experiment?

"Clinicaltrials.gov has listed this medical trial as an active recruitment and it was first posted on the 5th of March 2020, with its most recent edition being made on June 18th 2021."

Answered by AI

Has further research been conducted involving [68]Ga-HA-DOTATATE?

"As of now, 15 separate clinical trials are underway for [68]Ga-HA-DOTATATE. None of the active studies is in its final phase. Though most research sites are situated in Bethesda, Maryland, there exist 47 distinct locations studying this drug's efficacy."

Answered by AI

Has this type of research study been conducted previously?

"To date, 15 clinical trials for [68]Ga-HA-DOTATATE are being conducted in 13 countries and 19 cities. The initial study was sponsored by Ozmosis Research Inc., included 195 patients, and completed its drug approval phase back in 2016. Since then, two additional studies have been undertaken."

Answered by AI

How many individuals are being observed in this clinical experiment?

"Affirmative. According to the information on clinicaltrials.gov, this research endeavour is actively seeking candidates after being initially posted on March 5th 2020 and last updated June 18th 2021. 500 participants are required for a single trial site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03145857.

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