68Ga-HA-DOTATATE Imaging for Neuroendocrine Tumors

Overseen By Jonathan Abele, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Alberta

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging technique called 68Ga-HA-DOTATATE PET/CT to improve the detection of neuroendocrine tumors. These tumors often appear in the gut, pancreas, or lungs and are typically associated with somatostatin receptors. The trial aims to determine if this new method provides clearer and more accurate images than older techniques. Individuals who have or suspect they have these tumors and have undergone a CT or MRI scan in the past six months might be suitable for this trial. As a Phase 2 trial, the research focuses on evaluating the effectiveness of the treatment in an initial, smaller group, allowing participants to contribute to advancements in imaging technology.

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.

Is there any evidence suggesting that 68Ga-HA-DOTATATE is likely to be safe for humans?

Research has shown that 68Ga-HA-DOTATATE is generally safe for people. In earlier studies, no major side effects occurred after using 68Ga-DOTATATE for PET scans, meaning people did not require additional medical care due to the imaging agent. The safety profile is similar for both adults and children, indicating it is well-tolerated across different ages. While every medical treatment carries some risk, evidence so far suggests that 68Ga-HA-DOTATATE is a safe choice for imaging in individuals with tumors that have somatostatin receptors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 68Ga-HA-DOTATATE because it offers a new way to image neuroendocrine tumors using PET/CT scans. Unlike traditional imaging agents, 68Ga-HA-DOTATATE specifically targets somatostatin receptors, which are often overexpressed in these types of tumors. This targeted approach can provide clearer, more accurate images, helping doctors to better diagnose and monitor the progression of neuroendocrine tumors. Additionally, the use of a single-dose intravenous administration makes it a straightforward and potentially quicker process compared to other imaging methods.

What evidence suggests that 68Ga-HA-DOTATATE imaging is effective for neuroendocrine tumors?

Research has shown that 68Ga-DOTATATE PET/CT scans, which participants in this trial will receive, effectively diagnose neuroendocrine tumors. Studies indicate that this imaging method matches or surpasses older techniques like 111In-pentetreotide imaging. It provides clearer images and more accurate results, aiding doctors in locating both primary and metastatic tumors more easily. Importantly, studies report no serious side effects from using 68Ga-DOTATATE, making it a safe option for patients. This evidence supports its use in effectively identifying and managing neuroendocrine tumors. ^{4 6 7 8 9}

Who Is on the Research Team?

Jonathan Abele, MD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• 68Ga-HA-DOTATATE

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

(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]

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 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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6944175/

68Ga-DOTATOC Imaging of Neuroendocrine Tumors

Conclusion: 68Ga-DOTATOC is useful for evaluating the presence and extent in disease for staging and restaging and for assisting in treatment decision making ...

2.

jnm.snmjournals.org

jnm.snmjournals.org/content/57/5/708

Safety and Efficacy of 68Ga-DOTATATE PET/CT for Diagnosis ...

68 Ga-DOTATATE PET/CT was equivalent or superior to 111 In-pentetreotide imaging in all 78 patients. No adverse events requiring treatment were observed.

3.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.e16294

A reassessment of the clinical utility of 68 Ga-DOTATATE ...

The secondary objective was to determine if 68Ga-DOTATATE PET/CT was more effective in identifying primary or metastatic lesions compared to ...

4.

ajronline.org

ajronline.org/doi/10.2214/AJR.18.19881

Neuroendocrine Tumor Diagnosis and Management

Several studies have shown the high diagnostic accuracy of 68Ga-DOTATATE PET/CT in diagnosis of primary NETs compared with conventional imaging modalities.

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05673031

NCT05673031 | 68Ga-HA-DOTATATE PET/CT in Adults ...

The purpose of the current study will be to evaluate the usefulness of 68Ga-HA-DOTATATE compared to current standard anatomical imaging including CT, MRI, 111 ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5362940/

Safety and Efficacy of 68Ga-DOTATATE PET/CT ...

No adverse events requiring treatment were observed. 68Ga-DOTATATE PET/CT changed treatment in 36% of participants. Given the lack of significant toxicity, ...

7.

mayoclinic.org

mayoclinic.org/drugs-supplements/gallium-ga-68-dotatate-intravenous-route/description/drg-20312288

Gallium ga 68 dotatate (intravenous route) - Side effects & ...

Gallium Ga 68 dotatate injection is used with a PET scan (positron emission tomography) for localization of somatostatin receptor positive neuroendocrine ...

8.

novartis.com

novartis.com/us-en/sites/novartis_us/files/netspot.pdf

NetSpot

The safety profile of gallium Ga 68 dotatate is similar in adult and pediatric patients with somatostatin receptor positive tumors. The recommended gallium Ga ...

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accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2016/208547s000lbl.pdf

3939719 This label may not be the latest approved by FDA ...

The safety profile of Ga 68 dotatate is similar in adult and pediatric patients with somatostatin receptor positive tumors. The recommended Ga 68 dotatate ...