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68Ga-HA-DOTATATE Imaging for Neuroendocrine Tumors

Phase 2
Recruiting
Led By Jonathan Abele, MD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post-scan
Awards & highlights

Summary

This trial will assess the safety and effectiveness of a new radioisotope for imaging tumors. The new radioisotope is produced at the Edmonton Radiopharmaceutical Centre.

Who is the study for?
This trial is for patients with suspected or confirmed somatostatin receptor positive tumors, such as certain neuroendocrine tumors. Participants must have had a CT or MRI within the last 6 months and be able to consent. It's not for those who've had allergic reactions to DOTATATE, weigh over 225 kg, can't lie still for imaging due to conditions like extreme claustrophobia, or lack intravenous access.Check my eligibility
What is being tested?
The study tests the safety and diagnostic effectiveness of a new imaging agent called 68Ga-HA-DOTATATE in detecting somatostatin receptor positive tumors using PET scans. This could potentially offer better image quality and accuracy compared to older methods.See study design
What are the potential side effects?
While specific side effects are not listed, potential risks may include allergic reactions similar to previous allergies to DOTATATE or related compounds. The procedure involves lying still during PET scanning which might cause discomfort.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post-scan
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post-scan for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy - sensitivity
Efficacy - specificity
Secondary outcome measures
Safety - adverse events - delayed
Safety - adverse events - immediate
Safety - adverse events - post-scan

Trial Design

1Treatment groups
Experimental Treatment
Group I: 68Ga-HA-DOTATATE PET/CT scanExperimental Treatment1 Intervention
2.64 MBq/kg (minimum 37 MBq, maximum 250 MBq) 68Ga-HA-DOTATATE intravenous single-dose administration for PET/CT imaging

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Neuroendocrine Tumors (NETs) include somatostatin analogs, peptide receptor radionuclide therapy (PRRT), and molecular targeted therapies. Somatostatin analogs, such as octreotide and lanreotide, bind to somatostatin receptors on tumor cells, inhibiting hormone secretion and tumor growth. PRRT, like 177Lu-DOTATATE, combines a radioactive isotope with a somatostatin analog to deliver targeted radiation to the tumor cells, effectively killing them. Molecular targeted therapies, such as everolimus, inhibit pathways essential for tumor cell growth and survival. These targeted treatments are crucial for NET patients as they help manage symptoms, control tumor progression, and improve overall quality of life.
Advances and Current Concepts in the Medical Management of Gastroenteropancreatic Neuroendocrine Neoplasms.

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
901 Previous Clinical Trials
386,950 Total Patients Enrolled
3 Trials studying Neuroendocrine Tumors
1,250 Patients Enrolled for Neuroendocrine Tumors
Jonathan Abele, MDPrincipal InvestigatorUniversity of Alberta
1 Previous Clinical Trials
800 Total Patients Enrolled
1 Trials studying Neuroendocrine Tumors
800 Patients Enrolled for Neuroendocrine Tumors

Media Library

68Ga-HA-DOTATATE Clinical Trial Eligibility Overview. Trial Name: NCT04888481 — Phase 2
Neuroendocrine Tumors Research Study Groups: 68Ga-HA-DOTATATE PET/CT scan
Neuroendocrine Tumors Clinical Trial 2023: 68Ga-HA-DOTATATE Highlights & Side Effects. Trial Name: NCT04888481 — Phase 2
68Ga-HA-DOTATATE 2023 Treatment Timeline for Medical Study. Trial Name: NCT04888481 — Phase 2
~336 spots leftby Aug 2027