68Ga-HA-DOTATATE Imaging Of Suspected Somatostatin Receptor Positive Tumors
About the role
Actively Recruiting
Phase 2
All Genders
ID04888481
68Ga-HA-DOTATATE Imaging of Suspected Somatostatin Receptor Positive Tumors
Led by University of Alberta
Updated on 2026-05-11
600
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
Brief Title
Who Can Participate
AI-Screening
Your Study Journey
Trial Site Locations
Research Team
How is the study designed?
Similar Trials
Frequently Asked Questions
AI-Summary
What This Trial Is About
Researchers are evaluating the safety and diagnostic accuracy of 68Ga-HA-DOTATATE PETCT imaging for patients with known or suspected somatostatin receptor positive tumors, such as gastrointestinal, pancreatic, pulmonary neuroendocrine tumors, and others. This phase II, single-center, non-randomized study aims to assess this new tracer produced at the Edmonton Radiopharmaceutical Centre, comparing it to standard CT or MRI imaging over a one-year follow-up period. Participants will receive a single intravenous dose of 68Ga-HA-DOTATATE at 2.64 MBqkg, with a minimum of 37 MBq and maximum of 250 MBq, followed by PETCT scanning. Up to 600 scans will be performed over six years, including both adult and pediatric patients. Some patients may undergo multiple scans during the study. Safety will be monitored immediately after injection, post-scan, and at 10 days, while efficacy will be evaluated by comparing imaging results to clinical follow-up. During the study, participants will undergo PETCT scans and standard clinical CT or MRI within six months before enrollment. Adverse events will be tracked closely in the Nuclear Medicine department, and diagnostic accuracy will be assessed through sensitivity and specificity measures at one year post-scan. The study duration allows for comprehensive safety and efficacy evaluations, helping to inform clinical care for patients with these tumors.
CONDITIONS
Brief Title
68Ga-HA-DOTATATE Imaging of Suspected Somatostatin Receptor Positive Tumors
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
Patients with known or suspected somatostatin receptor positive tumors including gastrointestinal, pancreatic, pulmonary neuroendocrine tumors, and others Standard clinical CT or MRI obtained within 6 months of enrollment Ability to provide written informed consent or have a legal medical decision maker consent
You will not qualify if you...
Weight greater than 225 kg (PET/CT scanner limit) Inability to undergo scanning such as extreme claustrophobia or inability to lie still Any medical condition or serious illness that may interfere with study or interpretation Previous allergic reaction to DOTATATE or somatostatin analogues Lack of intravenous access
Research Team
J
Jonathan Abele, MD
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On this page
AI-Summary
Brief Title
Who Can Participate
AI-Screening
Your Study Journey
Trial Site Locations
Research Team
How is the study designed?
Similar Trials
Frequently Asked Questions
Sponsors
U
University of Alberta
Lead Sponsor
About DecenTrialz
DecenTrialz is the trusted digital partner for the clinical research ecosystem, dedicated to accelerating medical innovation by fundamentally democratizing access to clinical trials. Our unified platform is engineered to dismantle the systemic geographical, socioeconomic, and informational barriers that have long hindered participation, seamlessly connecting sponsors, CROs, and sites with a more diverse and engaged population of participants. Grounded in an unwavering commitment to trust, ethical principles, and regulatory compliance, we empower researchers with the intelligent tools needed for efficient recruitment while providing patients with a clear, secure, and accessible pathway to participation. Ultimately, our work forges a more inclusive and effective research landscape, speeding the delivery of life-changing therapies to humanity.
Vision:
We envision a world where clinical research is a shared global effort, not limited by geography, income, or background. In this future, every community has a seat at the table of discovery, and trials reflect the true diversity of humanity. By broadening access and accelerating participation, we aim to transform how quickly innovation turns into care, creating a healthier future that belongs to everyone.
Goals:
Our Goal is to democratize clinical research by opening participation to people everywhere and ensuring diverse voices are represented in discovery. We work to remove barriers that slow progress, so research can move faster and bring new treatments to patients who need them. By making trials more inclusive and representative, we aim to strengthen trust in science and ensure that Medical breakthroughs serve humanity as a whole.
Similar Jobs
68Ga-HA-DOTATATE Imaging Of Suspected Somatostatin Receptor Positive Tumors
About the role
Actively Recruiting
Phase 2
All Genders
ID04888481
68Ga-HA-DOTATATE Imaging of Suspected Somatostatin Receptor Positive Tumors
Led by University of Alberta
Updated on 2026-05-11
600
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
Brief Title
Who Can Participate
AI-Screening
Your Study Journey
Trial Site Locations
Research Team
How is the study designed?
Similar Trials
Frequently Asked Questions
AI-Summary
What This Trial Is About
Researchers are evaluating the safety and diagnostic accuracy of 68Ga-HA-DOTATATE PETCT imaging for patients with known or suspected somatostatin receptor positive tumors, such as gastrointestinal, pancreatic, pulmonary neuroendocrine tumors, and others. This phase II, single-center, non-randomized study aims to assess this new tracer produced at the Edmonton Radiopharmaceutical Centre, comparing it to standard CT or MRI imaging over a one-year follow-up period. Participants will receive a single intravenous dose of 68Ga-HA-DOTATATE at 2.64 MBqkg, with a minimum of 37 MBq and maximum of 250 MBq, followed by PETCT scanning. Up to 600 scans will be performed over six years, including both adult and pediatric patients. Some patients may undergo multiple scans during the study. Safety will be monitored immediately after injection, post-scan, and at 10 days, while efficacy will be evaluated by comparing imaging results to clinical follow-up. During the study, participants will undergo PETCT scans and standard clinical CT or MRI within six months before enrollment. Adverse events will be tracked closely in the Nuclear Medicine department, and diagnostic accuracy will be assessed through sensitivity and specificity measures at one year post-scan. The study duration allows for comprehensive safety and efficacy evaluations, helping to inform clinical care for patients with these tumors.
CONDITIONS
Brief Title
68Ga-HA-DOTATATE Imaging of Suspected Somatostatin Receptor Positive Tumors
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
Patients with known or suspected somatostatin receptor positive tumors including gastrointestinal, pancreatic, pulmonary neuroendocrine tumors, and others Standard clinical CT or MRI obtained within 6 months of enrollment Ability to provide written informed consent or have a legal medical decision maker consent
You will not qualify if you...
Weight greater than 225 kg (PET/CT scanner limit) Inability to undergo scanning such as extreme claustrophobia or inability to lie still Any medical condition or serious illness that may interfere with study or interpretation Previous allergic reaction to DOTATATE or somatostatin analogues Lack of intravenous access
Research Team
J
Jonathan Abele, MD
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
On this page
AI-Summary
Brief Title
Who Can Participate
AI-Screening
Your Study Journey
Trial Site Locations
Research Team
How is the study designed?
Similar Trials
Frequently Asked Questions
Sponsors
U
University of Alberta
Lead Sponsor
About DecenTrialz
DecenTrialz is the trusted digital partner for the clinical research ecosystem, dedicated to accelerating medical innovation by fundamentally democratizing access to clinical trials. Our unified platform is engineered to dismantle the systemic geographical, socioeconomic, and informational barriers that have long hindered participation, seamlessly connecting sponsors, CROs, and sites with a more diverse and engaged population of participants. Grounded in an unwavering commitment to trust, ethical principles, and regulatory compliance, we empower researchers with the intelligent tools needed for efficient recruitment while providing patients with a clear, secure, and accessible pathway to participation. Ultimately, our work forges a more inclusive and effective research landscape, speeding the delivery of life-changing therapies to humanity.
Vision:
We envision a world where clinical research is a shared global effort, not limited by geography, income, or background. In this future, every community has a seat at the table of discovery, and trials reflect the true diversity of humanity. By broadening access and accelerating participation, we aim to transform how quickly innovation turns into care, creating a healthier future that belongs to everyone.
Goals:
Our Goal is to democratize clinical research by opening participation to people everywhere and ensuring diverse voices are represented in discovery. We work to remove barriers that slow progress, so research can move faster and bring new treatments to patients who need them. By making trials more inclusive and representative, we aim to strengthen trust in science and ensure that Medical breakthroughs serve humanity as a whole.