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

TP
Overseen byTodd PW McMullen, MD, PhD, FRCSC, FACS
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: AHS Cancer Control Alberta
Disqualifiers: Pregnancy, Severe arthritis, Claustrophobia, others
No Placebo Group
Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests a new type of body scan for patients with certain types of tumors. The scan uses a small amount of radioactive material to highlight tumors by sticking to specific spots on them. It aims to show that this method is safe and more accurate than current scans. The new scan is useful for locating primary tumors in patients with certain types of cancer.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment [68]Ga-HA-DOTATATE for neuroendocrine tumors?

The research shows that 68Ga-DOTATATE PET/CT is a preferred imaging method for diagnosing and managing neuroendocrine tumors, helping doctors make better treatment decisions and improving patient outcomes.12345

Is [68]Ga-HA-DOTATATE safe for use in humans?

The available research on [68]Ga-DOTATATE, a similar compound, suggests it is generally safe for use in imaging neuroendocrine tumors. It is widely used for diagnosing and managing these tumors, and no significant safety concerns have been reported in the studies reviewed.26789

How does 68Ga-HA-DOTATATE imaging differ from other treatments for neuroendocrine tumors?

68Ga-HA-DOTATATE imaging is unique because it uses a special type of scan to detect neuroendocrine tumors by targeting somatostatin receptors, which are often present on these tumors. This method is more sensitive and accurate in identifying tumor locations compared to older imaging techniques like Octreoscan and MRI, making it a valuable tool for better diagnosis and management of these tumors.1351011

Research Team

TP

Todd PW McMullen, MD, PhD, FRCSC, FACS

Principal Investigator

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

Eligibility Criteria

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.

Inclusion Criteria

I have recent evidence or tests suggesting I might have a neuroendocrine tumor (NET).
A standard CT or MRI obtained within 6 months of enrolment is required
I am 14 years old or older.
See 4 more

Exclusion Criteria

I am allergic to DOTATATE or similar drugs.
Weight exceeding the PET/CT or PET/MR scanner limit
I cannot stay still for long periods due to a condition like severe arthritis.
See 3 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Safety Evaluation

Participants undergo [68]Ga-HA-DOTATATE PET/CT or PET/MRI scans to evaluate uptake by somatostatin receptor positive tumours. Safety evaluation includes vital signs, haematology, serum biochemistry, and adverse event assessment.

Up to 2 hours per scan
Up to 7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging, with follow-up scans evaluated for abnormal accumulation of [68]Ga-HA-DOTATATE.

Up to 6 years

Treatment Details

Interventions

  • [68]Ga-HA-DOTATATE (Radiopharmaceutical)
Trial Overview[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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

AHS Cancer Control Alberta

Lead Sponsor

Trials
188
Recruited
26,900+

Findings from Research

(68)Ga-DOTATATE PET/CT scanning is a safe and effective imaging method for neuroendocrine tumors, with a high sensitivity of 97% and specificity of 95.1%, leading to changes in treatment plans for 40.9% of patients based on unexpected findings.
Survival outcomes significantly vary based on tumor grade, with lower-grade tumors (G1) associated with better prognosis compared to higher grades (G2 and G3), and the presence of bone metastasis correlating with worse overall survival.
The Impact of 68Ga-DOTATATE PET/CT Imaging on Management of Patients with Neuroendocrine Tumors: Experience from a National Referral Center in the United Kingdom.Skoura, E., Michopoulou, S., Mohmaduvesh, M., et al.[2022]
68Ga-DOTATATE PET/CT is now the preferred imaging method for diagnosing well-differentiated neuroendocrine tumors (NETs) and is recommended by the National Comprehensive Cancer Network for patient management.
This imaging technique, when used alongside FDG PET/CT, allows for a noninvasive assessment of tumor heterogeneity, which is particularly beneficial for tailoring treatment strategies in patients with G2 and G3 NETs.
Neuroendocrine Tumor Diagnosis and Management: 68Ga-DOTATATE PET/CT.Sanli, Y., Garg, I., Kandathil, A., et al.[2019]
A survey of 88 referring physicians revealed that somatostatin receptor imaging with (68)Ga-DOTATATE PET/CT significantly influenced the management of neuroendocrine tumors, with 60% of patients experiencing changes in intended treatment plans.
DOTATATE imaging altered the suspicion for metastatic disease in 24% of cases, leading to important treatment adjustments, including 23% of patients switching from chemotherapy to alternative therapies.
Impact of 68Ga-DOTATATE PET/CT on the management of neuroendocrine tumors: the referring physician's perspective.Herrmann, K., Czernin, J., Wolin, EM., et al.[2022]

References

The Impact of 68Ga-DOTATATE PET/CT Imaging on Management of Patients with Neuroendocrine Tumors: Experience from a National Referral Center in the United Kingdom. [2022]
Neuroendocrine Tumor Diagnosis and Management: 68Ga-DOTATATE PET/CT. [2019]
Impact of 68Ga-DOTATATE PET/CT on the management of neuroendocrine tumors: the referring physician's perspective. [2022]
Ga-68 DOTATATE PET/CT and F-18 FDG PET/CT in the evaluation of low and intermediate versus high-grade neuroendocrine tumors. [2021]
High management impact of Ga-68 DOTATATE (GaTate) PET/CT for imaging neuroendocrine and other somatostatin expressing tumours. [2022]
Validation of Quality Control Parameters of Cassette-Based Gallium-68-DOTA-Tyr3-Octreotate Synthesis. [2022]
ACR Practice Parameter for the Performance of Gallium-68 DOTATATE PET/CT for Neuroendocrine Tumors. [2019]
68Ga-DOTATATE Compared with 111In-DTPA-Octreotide and Conventional Imaging for Pulmonary and Gastroenteropancreatic Neuroendocrine Tumors: A Systematic Review and Meta-Analysis. [2022]
Dynamic 68Ga-DOTA0-Tyr3-octreotate positron emission tomography-computed tomography for the evaluation of pancreatic neuroendocrine tumors: a pilot study. [2023]
Early experience with (68)Ga-DOTATATE preparation. [2015]
11.United Statespubmed.ncbi.nlm.nih.gov
The value of (68)Ga-DOTATATE PET/CT in diagnosis and management of neuroendocrine tumors compared to current FDA approved imaging modalities: a review of literature. [2022]