68Ga-DOTA-TATE Imaging for Neuroendocrine Cancer
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byÉric E Turcotte, MD
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Must not be taking: Somatostatin analogs
Disqualifiers: Pregnancy, Anaphylactic reaction, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 3 Jurisdictions
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.
12345Is 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.
13456How 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.
13457Eligibility 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
Informed consent by patient (or parents if patient is less than 18 years of age)
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.
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Neuroendocrine cancer patientsExperimental Treatment1 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)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Centre Intégré Universitaire de Santé et des Services Sociaux du Centre de l'Ouest de Montréal - Jewish General HospitalMontréal, Canada
CHUSSherbrooke, Canada
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Who Is Running the Clinical Trial?
Centre de recherche du Centre hospitalier universitaire de SherbrookeLead Sponsor
Jewish General HospitalCollaborator
Université de SherbrookeCollaborator
References
Validation of Quality Control Parameters of Cassette-Based Gallium-68-DOTA-Tyr3-Octreotate Synthesis. [2022]Gallium (Ga)-68-DOTA peptides targeting somatostatin receptors have been assessed as a valuable tool in neuroendocrine tumor imaging using positron emission tomography. However, at the moment, a specific monograph in the European Pharmacopoeia (Ph. Eur.) does exist only for Ga-68-edotreotide (DOTATOC) injection. Here, we report on the validation process of Ga-68-DOTA-Tyr3-octreotate (DOTATATE) cassette-based production and quality control (QC).
Impact of peptide receptor radionuclide therapy on the 68Ga-DOTATOC-PET/CT uptake in normal tissue. [2015]Positron-emission tomography/computed tomography (PET/CT) with [68Ga]DOTA0-Phe1-Tyr3-octreotide (68Ga-DOTA-TOC) became a standard for somatostatin receptor imaging. We investigated the potential changes of normal tissue uptake in patients with neuroendocrine tumor undergoing peptide receptor radionuclide therapy (PRRT).
68Ga-DOTATATE PET/CT versus 111In-octreotide scintigraphy in patients with neuroendocrine tumors: a prospective study. [2022]Label="OBJECTIVE" NlmCategory="OBJECTIVE">To compare 68Ga-DOTA-DPhe1,Tyr3-octreotate (68Ga-DOTATATE) positron-emission tomography/computed tomography (PET/CT) findings with those of conventional 111In-octreotide scintigraphy in patients with neuroendocrine tumors (NETs).
68Ga/177Lu-labeled DOTA-TATE shows similar imaging and biodistribution in neuroendocrine tumor model. [2017]Somatostatin receptors are overexpressed in neuroendocrine tumors, whose endogenous ligands are somatostatin. DOTA-TATE is an analogue of somatostatin, which shows high binding affinity to somatostatin receptors. We aim to evaluate the 68Ga/177Lu-labeling DOTA-TATE kit in neuroendocrine tumor model for molecular imaging and to try human-positron emission tomography/computed tomography imaging of 68Ga-DOTA-TATE in neuroendocrine tumor patients. DOTA-TATE kits were formulated and radiolabeled with 68Ga/177Lu for 68Ga/177Lu-DOTA-TATE (M-DOTA-TATE). In vitro and in vivo stability of 177Lu-DOTA-TATE were performed. Nude mice bearing human tumors were injected with 68Ga-DOTA-TATE or 177Lu-DOTA-TATE for micro-positron emission tomography and micro-single-photon emission computed tomography/computed tomography imaging separately, and clinical positron emission tomography/computed tomography images of 68Ga-DOTA-TATE were obtained at 1 h post-intravenous injection from patients with neuroendocrine tumors. Micro-positron emission tomography and micro-single-photon emission computed tomography/computed tomography imaging of 68Ga-DOTA-TATE and 177Lu-DOTA-TATE both showed clear tumor uptake which could be blocked by excess DOTA-TATE. In addition, 68Ga-DOTA-TATE-positron emission tomography/computed tomography imaging in neuroendocrine tumor patients could show primary and metastatic lesions. 68Ga-DOTA-TATE and 177Lu-DOTA-TATE could accumulate in tumors in animal models, paving the way for better clinical peptide receptor radionuclide therapy for neuroendocrine tumor patients in Asian population.
Dynamic 68Ga-DOTA0-Tyr3-octreotate positron emission tomography-computed tomography for the evaluation of pancreatic neuroendocrine tumors: a pilot study. [2023]Label="Background" NlmCategory="UNASSIGNED"> 68Ga-DOTA0-Tyr3-octreotate (68Ga-DOTATATE) is a radiolabeled somatostatin analog used for the diagnosis of pancreatic neuroendocrine tumors (pNETs), and standardized uptake value (SUV) measurements for therapeutic monitoring is recommended. However, changes in net influx rate (Ki) may better reflect treatment effects than may those of the SUV. The aim of this study was to investigate the value of dynamic 68Ga-DOTATATE positron emission tomography-computed tomography (PET-CT) in the evaluation of pNETs.
The value of [68Ga]Ga-DOTA-TATE PET/CT in diagnosis and management of suspected pituitary tumors. [2021]Gallium 68-tetraazacyclododecane-tetraacetic acid-octreotate ([68Ga]Ga-DOTA-TATE) is a selective somatostatin analogue ligand, which shows increased affinity for somatostatin receptor subtype (SSTR) 2 and has been used routinely for imaging neuroendocrine tumors with PET/CT. We investigated the utility of [68Ga]Ga-DOTA-TATE positron emission tomography/computed tomography (PET/CT) in patients with suspected pituitary pathology. We reviewed imaging for twenty consecutive patients (8 men, 12 women, mean age of 48.2, range 14-78) with suspected pituitary pathology who were referred for [68Ga]Ga-DOTA-TATE PET/CT.
Intraindividual comparison of 68Ga-DOTA-TATE and 18F-DOPA PET in patients with well-differentiated metastatic neuroendocrine tumours. [2021]To compare the diagnostic impact of (68)Ga-DOTA-TATE and (18)F-DOPA PET in the diagnosis of well-differentiated metastatic neuroendocrine tumours (NET).