68Ga-HA-DOTATATE Imaging for Neuroendocrine Tumors

Recruiting in Palo Alto (17 mi)

Overseen by Jonathan Abele, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Alberta

Disqualifiers: Weight > 225 kg, Claustrophobia, Allergic to DOTATATE, others

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing a new imaging scan for patients with specific types of tumors. The scan uses a special substance to make the tumors more visible. It aims to provide better images for accurate diagnosis and monitoring.

Do I need to stop my current medications for this 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 drug 68Ga-HA-DOTATATE for neuroendocrine tumors?

Research shows that Ga-68 DOTATATE PET/CT imaging is effective in identifying neuroendocrine tumors and provides better diagnostic information compared to conventional methods, which can significantly impact patient management. ^{1 2 3 4 5}

Is 68Ga-DOTATATE safe for humans?

68Ga-DOTATATE is generally considered safe for use in humans as an imaging agent for neuroendocrine tumors. It is a radiolabeled peptide that targets specific receptors on tumors, and while it is effective for imaging, the studies do not report significant safety concerns. ^{1 4 5 6 7}

How is 68Ga-HA-DOTATATE imaging different from other treatments for neuroendocrine tumors?

68Ga-HA-DOTATATE imaging is unique because it uses a special tracer that targets somatostatin receptors, which are often present on neuroendocrine tumors. This allows for more precise imaging compared to traditional methods, helping doctors better identify and manage these tumors. ^{1 3 4 5 8}

Research Team

Jonathan Abele, MD

Principal Investigator

University of Alberta

Eligibility Criteria

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.

Inclusion Criteria

My tumor is suspected to be positive for somatostatin receptors.

Ability to provide written informed consent prior to participation in the study (participant or if required a legal medical decision maker)

A standard clinical CT or MRI is obtained within 6 months of enrollment

Exclusion Criteria

Previous allergic reaction to DOTATATE or somatostatin analogues

Lack of intravenous access

Any additional medical condition, serious inter-current illness, or other extenuating circumstance that, in the opinion of the investigator or attending department physician, may significantly interfere with study performance or interpretation

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants receive a single-dose administration of 68Ga-HA-DOTATATE for PET/CT imaging

1 day

1 visit (in-person)

Safety Evaluation

Assessment of adverse events immediately after tracer injection and PET/CT scan

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a 1-year clinical follow-up

1 year

Treatment Details

Interventions

• 68Ga-HA-DOTATATE (Radiopharmaceutical)

Trial Overview 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.

Participant Groups

Group I: 68Ga-HA-DOTATATE PET/CT scan Experimental Treatment 1 Intervention

2.64 MBq/kg (minimum 37 MBq, maximum 250 MBq) 68Ga-HA-DOTATATE intravenous single-dose administration for PET/CT imaging

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Bill Flanagan

University of Alberta

Chief Executive Officer since 2020

LLB from University of Toronto, LLM from Columbia University

Dr. Verna Yiu

University of Alberta

Chief Medical Officer since 2012

MD from University of Alberta, Fellowship in Pediatric Nephrology at Harvard University

Findings from Research

68 Ga-DOTATATE PET/CT imaging proved effective in identifying previously unknown primary tumors and metastatic disease in sinonasal neuroendocrine tumors, highlighting its potential for better diagnosis compared to conventional imaging methods.

In two cases of esthesioneuroblastoma, 68 Ga-DOTATATE detected abnormal uptake that was not visible on 18F-FDG PET/CT, suggesting it may be crucial for treatment planning, including identifying candidates for targeted therapies like 177 Lu-DOTATATE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of 68 Gallium-DOTATATE PET/CT in sinonasal neuroendocrine tumor management: A case series. Liu, KY., Goldrich, DY., Ninan, SJ., et al.[2021]

In a patient with a well-differentiated stage IV neuroendocrine tumor, there was an unusual case of increased blood pool uptake of 68Ga-DOTATATE, which could affect the accuracy of treatment response assessments during PET/CT scans.

This transient increase in blood pool accumulation of 68Ga, likely due to unbound radiopharmaceutical, highlights the need for careful interpretation of PET/CT results to avoid misleading conclusions about treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unusual Increased Blood Pool Activity on 68Ga-DOTATATE PET/CT in a Patient With Metastatic Neuroendocrine Disease. Sharma, A., Navaz, AJ., Pandey, MK., et al.[2023]

In a study of 81 patients with neuroendocrine tumors (NETs), Ga-68 DOTATATE PET/CT was more effective than F-18 FDG PET/CT in detecting positive scans in patients with low and intermediate-grade tumors, with 82.1% of DOTATATE scans positive compared to 54.5% for FDG (P = 0.04).

For high-grade, poorly-differentiated NETs, both DOTATATE and FDG PET/CT scans were equally effective, with all patients showing positive results, indicating that while DOTATATE is superior for lower-grade tumors, it does not provide additional benefits for high-grade tumors compared to FDG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ga-68 DOTATATE PET/CT and F-18 FDG PET/CT in the evaluation of low and intermediate versus high-grade neuroendocrine tumors. You, H., Kandathil, A., Beg, M., et al.[2021]

Ga-68 DOTATATE PET/CT imaging provided additional diagnostic information in 68% of patients compared to conventional imaging and 83% compared to In-111 octreotide imaging, with 88% of the studies showing abnormalities.

The management impact of GaTate PET/CT was significant, with 47% of patients experiencing high management changes, such as being directed to curative surgery or systemic therapy, highlighting its potential to improve treatment outcomes for neuroendocrine tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High management impact of Ga-68 DOTATATE (GaTate) PET/CT for imaging neuroendocrine and other somatostatin expressing tumours. Hofman, MS., Kong, G., Neels, OC., et al.[2022]

Gallium-68-dotatate PET/CT imaging demonstrated high sensitivity (94.16%) and specificity (91.89%) in detecting neuroendocrine tumors (NET) and other somatostatin expressing tumors, outperforming traditional CT scans.

In a study of 203 patients, PET/CT identified disease in 19 cases where CT was falsely negative, highlighting its superior ability to detect primary tumor sites and inform patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gallium-68-dotatate PET/CT is better than CT in the management of somatostatin expressing tumors: First experience in Africa. Lawal, IO., Ololade, KO., Lengana, T., et al.[2019]

The validation of Ga-68-DOTA-Tyr3-octreotate (DOTATATE) production showed that it meets all European Pharmacopoeia quality control standards, with radiochemical purity consistently above 99% across three production runs.

The successful validation process ensures that Ga-68-DOTATATE is a reliable and safe radiopharmaceutical for neuroendocrine tumor imaging, demonstrating reproducibility in quality and efficacy for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of Quality Control Parameters of Cassette-Based Gallium-68-DOTA-Tyr3-Octreotate Synthesis. Sammartano, A., Migliari, S., Scarlattei, M., et al.[2022]

In a study of 237 patients undergoing Ga-68 DOTATATE PET/CT for neuroendocrine tumors, 11% exhibited atypical thyroid uptake, indicating a notable occurrence that warrants further investigation.

Among patients with focal uptake, 71% had thyroid nodules, and 21% were diagnosed with papillary thyroid cancer, highlighting the importance of clinical evaluation for potential malignancies in these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Rate and Clinical Significance of Incidental Thyroid Uptake as Detected by Gallium-68 DOTATATE Positron Emission Tomography/Computed Tomography. Nockel, P., Millo, C., Keutgen, X., et al.[2019]

(68)Ga-DOTATATE PET/CT demonstrated a high sensitivity of 90% and specificity of 82% in detecting recurrent neuroendocrine tumors (NETs) in a study of 63 patients, indicating it is an effective diagnostic tool for monitoring these tumors after curative resection.

The study highlighted that while (68)Ga-DOTATATE PET/CT is accurate, the sensitivity decreased when the scans were reviewed without clinical context, emphasizing the importance of integrating clinical information in the evaluation of NET recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroendocrine tumor recurrence: diagnosis with 68Ga-DOTATATE PET/CT. Haug, AR., Cindea-Drimus, R., Auernhammer, CJ., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

The value of 68 Gallium-DOTATATE PET/CT in sinonasal neuroendocrine tumor management: A case series. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Unusual Increased Blood Pool Activity on 68Ga-DOTATATE PET/CT in a Patient With Metastatic Neuroendocrine Disease. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Ga-68 DOTATATE PET/CT and F-18 FDG PET/CT in the evaluation of low and intermediate versus high-grade neuroendocrine tumors. [2021]

4. Australia pubmed.ncbi.nlm.nih.gov

High management impact of Ga-68 DOTATATE (GaTate) PET/CT for imaging neuroendocrine and other somatostatin expressing tumours. [2022]

5. Greece pubmed.ncbi.nlm.nih.gov

Gallium-68-dotatate PET/CT is better than CT in the management of somatostatin expressing tumors: First experience in Africa. [2019]

6. India pubmed.ncbi.nlm.nih.gov

Validation of Quality Control Parameters of Cassette-Based Gallium-68-DOTA-Tyr3-Octreotate Synthesis. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The Rate and Clinical Significance of Incidental Thyroid Uptake as Detected by Gallium-68 DOTATATE Positron Emission Tomography/Computed Tomography. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Neuroendocrine tumor recurrence: diagnosis with 68Ga-DOTATATE PET/CT. [2022]