68Ga-DOTA-TATE Imaging for Neuroendocrine Cancer

Recruiting at 1 trial location

Overseen By Stéphanie Dubreuil

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Must not be taking: Somatostatin analogs

Disqualifiers: Pregnancy, Anaphylactic reaction, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

5000 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial is a pragmatic study aiming to evaluate the innocuity/safety profile of the PET radiotracer 68Ga-DOTA-TATE, and to establish the procedure as a routine standard-of-care diagnostic tool for all neuro-endocrine cancer patients. It is a single-center study, but with recruitment across all Canada. The trial is prospective, non-randomized, open-label and with no control group. The superiority of this procedure over the former standard-of-care (Octreoscan) was already established in previous and numerous studies across the world. As such, the current trial aims to gather data to further support the implementation of 68Ga-DOTA-TATE as the new standard-of-care for neuro-endocrine tumors (NET).

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment 68Ga-DOTA-TATE for neuroendocrine cancer?

Research shows that 68Ga-DOTA-TATE is effective in imaging neuroendocrine tumors by binding to somatostatin receptors, which are commonly found in these tumors. Studies have demonstrated that it can clearly show both primary and metastatic lesions in patients, making it a valuable tool for diagnosing and monitoring neuroendocrine cancer. ^{1 2 3 4 5}

Is 68Ga-DOTA-TATE safe for use in humans?

68Ga-DOTA-TATE has been used in imaging for neuroendocrine tumors and has shown clear tumor uptake in both animal models and human patients, indicating it is generally safe for use in humans. ^{1 3 4 5 6}

How is the drug 68Ga-DOTA-TATE different from other treatments for neuroendocrine cancer?

68Ga-DOTA-TATE is unique because it is a radiolabeled somatostatin analog that specifically targets somatostatin receptors, which are often overexpressed in neuroendocrine tumors. This allows for precise imaging of both primary and metastatic lesions using PET/CT scans, offering a more accurate diagnosis compared to traditional imaging methods like 111In-octreotide scintigraphy. ^{1 3 4 5 7}

Research Team

Éric E Turcotte, MD

Principal Investigator

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Eligibility Criteria

This trial is for patients across Canada with suspected or confirmed neuroendocrine tumors that express somatostatin receptors. They must have a doctor's referral for the PET/CT scan and give informed consent. It's not suitable for those who refuse to participate, are pregnant without careful consideration of risks, or have had severe allergic reactions to DOTA-TATE or similar drugs.

Inclusion Criteria

My tumor is suspected to or does express somatostatin receptors.

My doctor has requested a specific PET/CT scan for me.

Exclusion Criteria

I do not want to participate in the clinical trial.

I am pregnant and have a life-threatening condition that may require diagnostic procedures.

You had a serious allergic reaction in the past to DOTA-TATE or similar medications.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Safety Monitoring

Participants receive an intravenous injection of 68Ga-DOTA-TATE and undergo PET/CT imaging. Safety profile, adverse effects, and biodistribution of the radiotracer are monitored.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging. They are advised to report any adverse events within 48 hours post-scan.

1 week

1 follow-up call

Long-term Monitoring

Long-term monitoring of the safety profile and diagnostic impact of 68Ga-DOTA-TATE on patient management over a 5-year period.

5 years

Treatment Details

Interventions

• 68Ga-DOTA-TATE

Trial Overview The study tests the safety of 68Ga-DOTA-TATE PET/CT imaging as a routine diagnostic tool for neuroendocrine cancer patients. This single-center, non-randomized trial seeks to establish this method over Octreoscan based on prior evidence supporting its superiority.

Participant Groups

Group I: Neuroendocrine cancer patients Experimental Treatment 1 Intervention

All neuroendocrine cancer patients referred by their physician and fulfilling the eligibility criteria across Canada can be recruited to the primary site of the study. Patients will be injected intravenously with 3 MBq/kg (maximum 370 MBq) of 68Ga-DOTA-TATE. 45-90 minutes following injection, patients will be imaged in a PET/CT scanner. Images will be analyzed by a trained nuclear medicine physician. Safety profile, eventual adverse effects, false positives, false negatives and any abnormal biodistribution of the radiotracer will be monitored and analysed.

68Ga-DOTA-TATE is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Gallium-68 DOTATATE for:

• Localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adults

Approved in European Union as Gallium-68 DOTATATE for:

• Diagnosis and staging of neuroendocrine tumors (NETs)

Approved in Canada as Gallium-68 DOTATATE for:

• Diagnosis and staging of neuroendocrine tumors (NETs)

Who Is Running the Clinical Trial?

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Lead Sponsor

Trials

64

Recruited

33,600+

Jewish General Hospital

Collaborator

Trials

144

Recruited

283,000+

Université de Sherbrooke

Collaborator

Trials

317

Recruited

79,300+

Findings from Research

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 involving 16 patients with neuroendocrine tumors, the uptake of the imaging agent [68Ga]DOTA-TOC in normal tissues remained stable before and after undergoing peptide receptor radionuclide therapy (PRRT), indicating that PRRT does not significantly alter normal tissue uptake.

The consistent uptake values across various organs suggest that the tumor-to-non-tumor ratio remains a reliable biomarker for monitoring therapy effectiveness, as there were no significant changes in the maximum standardized uptake values (SUVmax) in organs like the pituitary, thyroid, and kidneys.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of peptide receptor radionuclide therapy on the 68Ga-DOTATOC-PET/CT uptake in normal tissue. Giesel, FL., Stefanova, M., Schwartz, LH., et al.[2015]

In a study of 41 patients with neuroendocrine tumors, 68Ga-DOTATATE PET/CT imaging identified more lesions compared to conventional 111In-octreotide scintigraphy, particularly in the liver and bowel.

The additional information from 68Ga-DOTATATE PET/CT led to changes in treatment management for 12.2% of patients, highlighting its superior efficacy in accurately assessing disease extent and informing treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-DOTATATE PET/CT versus 111In-octreotide scintigraphy in patients with neuroendocrine tumors: a prospective study. Cavicchioli, M., Bitencourt, AGV., Lima, ENP.[2022]

The study demonstrated that both 68Ga-DOTA-TATE and 177Lu-DOTA-TATE effectively accumulate in neuroendocrine tumors in animal models, indicating their potential for targeted imaging and therapy.

Clinical imaging with 68Ga-DOTA-TATE in neuroendocrine tumor patients successfully identified primary and metastatic lesions, suggesting its utility in improving diagnosis and treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga/177Lu-labeled DOTA-TATE shows similar imaging and biodistribution in neuroendocrine tumor model. Liu, F., Zhu, H., Yu, J., et al.[2017]

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]

In a study of 20 patients with suspected pituitary pathology, [68Ga]Ga-DOTA-TATE PET/CT effectively identified recurrent Cushing's disease, showing positive uptake in all seven patients, while it was absent in cases of ectopic ACTH secretion.

The imaging technique also successfully localized ectopic ACTH tumors in six out of eight patients with Cushing's syndrome, demonstrating its utility in cases where traditional imaging methods were inconclusive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of [68Ga]Ga-DOTA-TATE PET/CT in diagnosis and management of suspected pituitary tumors. Novruzov, F., Aliyev, A., Wan, MYS., et al.[2021]

In a study of 25 patients with metastatic neuroendocrine tumors (NET), (68)Ga-DOTA-TATE PET demonstrated a significantly higher sensitivity (96%) for detecting tumors compared to (18)F-DOPA PET (56%).

(68)Ga-DOTA-TATE PET was superior in delineating metastatic regions, identifying 54 out of 55 positive areas, while (18)F-DOPA PET identified only 29, suggesting that (68)Ga-DOTA-TATE is the preferred imaging method for diagnosing and staging NET.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraindividual comparison of 68Ga-DOTA-TATE and 18F-DOPA PET in patients with well-differentiated metastatic neuroendocrine tumours. Haug, A., Auernhammer, CJ., Wängler, B., et al.[2021]

References

1. India pubmed.ncbi.nlm.nih.gov

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

2. Italy pubmed.ncbi.nlm.nih.gov

Impact of peptide receptor radionuclide therapy on the 68Ga-DOTATOC-PET/CT uptake in normal tissue. [2015]

3. Brazil pubmed.ncbi.nlm.nih.gov

68Ga-DOTATATE PET/CT versus 111In-octreotide scintigraphy in patients with neuroendocrine tumors: a prospective study. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

68Ga/177Lu-labeled DOTA-TATE shows similar imaging and biodistribution in neuroendocrine tumor model. [2017]

5. China 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. [2023]

6. England pubmed.ncbi.nlm.nih.gov

The value of [68Ga]Ga-DOTA-TATE PET/CT in diagnosis and management of suspected pituitary tumors. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Intraindividual comparison of 68Ga-DOTA-TATE and 18F-DOPA PET in patients with well-differentiated metastatic neuroendocrine tumours. [2021]