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New treatment option for Neuroendocrine Tumors
Official title 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 ID: NCT03145857
What this study is testing
What is [68]Ga-HA-DOTATATE?
[68]Ga-HA-DOTATATE is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for neuroendocrine tumors.
Also referred to as Gallium-68 high affinity-DOTATATE, Gallium-68 DOTA-3-iodo-Tyr(3)-octreotate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 and older
You may be able to join if
- Known or suspected somatostatin receptor positive tumour including, but not limited to, GNET, PNET, pulmonary NET, PRUNK NET, pheochromocytoma...
- 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 likely can't join 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...
- Any additional medical condition, serious inter-current illness or other extenuating circumstance that, in the opinion of the Investigator, may...
- Weight exceeding the PET/CT or PET/MR scanner limit;
- Pregnancy;
- Allergic reaction to DOTATATE or somatostatin analogues.
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.