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

Overseen By NET Coordinator

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: AHS Cancer Control Alberta

Disqualifiers: Pregnancy, Severe arthritis, Claustrophobia, others

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

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

Compensation: Varies

Number of Visits: 7

1534 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new scanning method, [68]Ga-HA-DOTATATE PET/CT or PET/MRI, to determine its safety and effectiveness in detecting certain tumors, particularly neuroendocrine tumors (NETs). These tumors often have somatostatin receptors, which the scan can highlight. This method may offer more accuracy than the current Octreoscan™. Participants should have a known or suspected somatostatin receptor-positive tumor and a recent CT scan. This trial seeks individuals interested in advancing how doctors diagnose these tumors. As a Phase 1, Phase 2 trial, the research aims to understand how the scanning method works in people and measure its effectiveness in an initial group, offering participants a chance to contribute to advancements in tumor detection.

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 prior data suggests that [68]Ga-HA-DOTATATE is safe for imaging neuroendocrine tumors?

Research has shown that [68]Ga-DOTATATE, similar to [68]Ga-HA-DOTATATE, is generally safe and well-tolerated. In studies, patients experienced few side effects, typically mild ones like nausea or headaches. This suggests that [68]Ga-HA-DOTATATE should have a similar safety profile.

Additionally, the FDA has approved a similar product, [64Cu]Cu-DOTA-TATE, which provides some reassurance about its safety. However, since this trial remains in the early stages, ongoing evaluation is necessary to fully confirm safety. Overall, early findings indicate that the treatment is likely to be well-tolerated in people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard imaging methods for neuroendocrine tumors, such as CT or MRI scans alone, [68]Ga-HA-DOTATATE is a radiotracer that specifically targets somatostatin receptors on tumor cells. This makes it possible to visualize tumors more precisely using PET/CT or PET/MRI scans. Researchers are excited because this targeted approach can potentially improve the accuracy of tumor detection and monitoring, enabling more personalized treatment plans for patients. Plus, the ability to perform multiple scans as needed offers flexibility in assessing how well a treatment is working over time.

What evidence suggests that [68]Ga-HA-DOTATATE is effective for diagnosing neuroendocrine tumors?

Research has shown that [68]Ga-HA-DOTATATE PET scans, which participants in this trial will undergo, effectively detect neuroendocrine tumors (NETs). These scans highlight specific receptors commonly found on these tumors. Studies indicate that similar scans, such as [68]Ga-DOTATATE, surpass older ones like the Octreoscan™ in accuracy, allowing for more precise tumor localization. These scans are crucial because they offer clearer and more detailed images, aiding doctors in making more accurate diagnoses. ^{1 5 6 7 8}

Who Is on the Research Team?

Todd PW McMullen, MD, PhD, FRCSC, FACS

Principal Investigator

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

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• [68]Ga-HA-DOTATATE

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.

How Is the Trial Designed?

Group I: [68]Ga-HA-DOTATATE Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

AHS Cancer Control Alberta

Lead Sponsor

Trials

188

Recruited

26,900+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

(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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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]

(68)Ga-DOTATATE PET/CT is a highly effective imaging technique for detecting neuroendocrine tumors (NETs), outperforming traditional methods like Octreoscan, MIBG scintigraphy, and MRI.

The review highlights the growing interest in using (68)Ga-DOTATATE PET/CT for the diagnosis and management of NETs, indicating its potential to improve patient outcomes in clinical settings.

NCBI (Pubmed)

pubmed.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. Mojtahedi, A., Thamake, S., Tworowska, I., et al.[2022]

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 imaging shows significantly higher sensitivity (90.9%) and specificity (90.6%) for diagnosing neuroendocrine tumors (NETs) compared to octreotide and conventional imaging methods, based on a systematic review of 42 studies.

The safety profile of (68)Ga-DOTATATE is favorable, with only 6 reported cases of harm out of 974 subjects, and no major toxicity or safety issues identified, supporting its use for NET imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-DOTATATE Compared with 111In-DTPA-Octreotide and Conventional Imaging for Pulmonary and Gastroenteropancreatic Neuroendocrine Tumors: A Systematic Review and Meta-Analysis. Deppen, SA., Blume, J., Bobbey, AJ., et al.[2022]

(68)Ga-DOTATATE is a highly sensitive imaging agent for detecting low-grade neuroendocrine tumors (NETs), outperforming other imaging methods like (18)F-FDG and (111)In-DTPA-octreotide in identifying well-differentiated metastatic NETs.

In a small study of 6 cases, (68)Ga-DOTATATE successfully detected all known NET sites and even revealed an unknown peritoneal metastasis, highlighting its potential for routine clinical use in PET imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early experience with (68)Ga-DOTATATE preparation. Saw, MM.[2015]

Gallium-68 DOTA-Tyr-octreotatate (Ga-DOTATATE) PET/CT imaging is highly effective for managing neuroendocrine tumors, leading to a change in treatment for about 75% of patients compared to traditional imaging methods.

Ga-DOTATATE PET/CT is particularly useful for identifying well-differentiated tumors that express somatostatin receptors, while dedifferentiated tumors may require F FDG PET/CT for detection, highlighting the complementary nature of these imaging techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ACR Practice Parameter for the Performance of Gallium-68 DOTATATE PET/CT for Neuroendocrine Tumors. Subramaniam, RM., Bradshaw, ML., Lewis, K., et al.[2019]

Dynamic 68Ga-DOTATATE PET-CT scans in 7 patients with localized pancreatic neuroendocrine tumors (pNETs) showed that the tumors had significantly higher uptake values (SUVmax and SUVmean) compared to normal pancreatic tissue, indicating effective tumor visualization.

The study found that the net influx rate (Ki) of pNETs was also significantly higher than that of normal tissue, suggesting that Ki may be a more reliable measure for evaluating treatment effects than standardized uptake values (SUV).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic 68Ga-DOTA0-Tyr3-octreotate positron emission tomography-computed tomography for the evaluation of pancreatic neuroendocrine tumors: a pilot study. Yin, H., Liu, G., Tan, H., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4402678/

comparative preclinical evaluation of [68Ga]DOTATATE ... The present preclinical data fully confirm the general biodistribution pattern and excellent in vivo sst-targeting characteristics previously observed for [ 68 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/17401086/

68Ga-DOTA-Tyr3-octreotide PET in neuroendocrine tumors Conclusion: (68)Ga-DOTA-TOC PET shows a significantly higher detection rate compared with conventional somatostatin receptor scintigraphy and diagnostic CT with ...

3. theranostictrials.org theranostictrials.org/studies/clsupk86p001m11uj15qkqqls

NeuroEndocrine (NEC) (Multiple Types) Somatostatin receptor (SSR) imaging is a critical component of clinical care for many patients being investigated for or with confirmed SSR positive tumors. In ...

4. frontiersin.org frontiersin.org/journals/nuclear-medicine/articles/10.3389/fnume.2025.1655419/pdf

Targeted radionuclide therapy and diagnostic imaging of ... The most recent FDA- approved radiopharmaceutical for NET imaging is [64Cu]Cu-. DOTA-TATE (Detectnet), which was FDA-approved in 2020. (12).

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. clinicaltrials.gov clinicaltrials.gov/study/NCT01619865?tab=results

Study Results | Safety of 68Ga-DOTA-tyr3-Octreotide PET ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

7. frontiersin.org frontiersin.org/journals/nuclear-medicine/articles/10.3389/fnume.2025.1655419/pdf?ref=counterforcehealth.org

Targeted radionuclide therapy and diagnostic imaging of ... The most recent FDA- approved radiopharmaceutical for NET imaging is [64Cu]Cu-. DOTA-TATE (Detectnet), which was FDA-approved in 2020. (12).

8. researchgate.net researchgate.net/figure/nternalization-of-68-GaDOTATATE-68-GaHA-DOTATATE-177-LuHA-DOTATATE-and-the_fig4_275585898

Internalization of [ 68 Ga]DOTATATE ... IHC analysis indicates that up to 50% of SCLC tumors are SSTR2-positive, with a substantial subset showing high and homogenous expression. Peptide receptor ...