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Radioactive Agent

Gallium Dotatate for Pancreatic Neuroendocrine Tumors

Q: Is participation in this trial open to octogenarians?

To be eligible for this medical trial, individuals must between 19 and 100 years of age. For those below 18 or over 65, there are 27 trials and 686 trials respectively available to them.

Q: Are there any openings for participants in this clinical experiment currently?

Indeed, clinicaltrials.gov currently reveals that this medical trial is searching for participants. This study was initially shared on June 7th 2019 and underwent its latest update on July 26th 2022.

Q: What is the scope of this research project in terms of participants?

Affirmative. Clinicaltrials.gov has the most recent information indicating that this clinical trial is presently seeking volunteers; it was initially launched on June 7th, 2019 and its details were most recently updated on July 26th 2022. The study requires 12 participants from a single site to be enrolled in total.

Q: What other investigations have utilized Gallium Dotatate to test its effects?

Presently, 15 clinical trials are researching Gallium Dotatate; none of them have reached Phase 3. While the principal research for this treatment is conducted in Bethesda, <a href="https://www.withpower.com/clinical-trials/maryland">Maryland</a>., 47 sites across the US are currently running relevant studies.

Q: What criteria must be met for individuals to qualify for participation in this clinical trial?

The requisite qualifications for this research trial involve having a pancreatic diagnosis and being between 19 to 100 years old. Currently, there are 12 participants enrolled in the program.

Q: Is this clinical trial pioneering any new territory?

Currently, 15 active research projects utilizing Gallium Dotatate are underway across 19 cities and 13 countries. The first investigation was funded by Ozmosis Research Inc., in 2016 with a cohort of 195 participants who completed the necessary stages for drug approval. Since then, two additional trials have been launched.

Phase < 1

Waitlist Available

Led By Sushanth Reddy, MD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline through 12 months

Awards & highlights

Study Summary

This trial will test if using a PET/CT scan with NETSPOT can more accurately find neuroendocrine tumors, making it easier to remove them during surgery.

Eligible Conditions

Pancreatic Neuroendocrine Tumors
Carcinoid Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline through 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline through 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline through 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Comparison of intraoperative findings to preoperative PET scan findings

Secondary outcome measures

Determine threshold levels of gallium dotatate uptake in order to determine tumor involvement

Trial Design

1Treatment groups

Experimental Treatment

Group I: Gallium DotatateExperimental Treatment1 Intervention

All patients in the study will be undergoing both a 68Gallium-DOTATATE scan for tumor localization and planned surgical resection. Both of these maneuvers are clinically indicated and the standard of care in the care of these patients. Following induction of general endotracheal anesthesia (as required for the surgery portion of treatment), the patients will receive an additional injection of 68Gallium-DOTATATE in the operating room itself. A probe that can detect 68Gallium will be used to identify tumors in the OR within the patient's abdominal cavity for targeted resection.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,581 Previous Clinical Trials

2,278,029 Total Patients Enrolled

Sushanth Reddy, MDPrincipal Investigator - University of Alabama at Birmingham

Birmingham VA Medical Center

University Of Alabama School Of Medicine (Medical School)

University Of Ky A B Chandler (Residency)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this trial open to octogenarians?

"To be eligible for this medical trial, individuals must between 19 and 100 years of age. For those below 18 or over 65, there are 27 trials and 686 trials respectively available to them."

Answered by AI

Are there any openings for participants in this clinical experiment currently?

"Indeed, clinicaltrials.gov currently reveals that this medical trial is searching for participants. This study was initially shared on June 7th 2019 and underwent its latest update on July 26th 2022."

Answered by AI

What is the scope of this research project in terms of participants?

"Affirmative. Clinicaltrials.gov has the most recent information indicating that this clinical trial is presently seeking volunteers; it was initially launched on June 7th, 2019 and its details were most recently updated on July 26th 2022. The study requires 12 participants from a single site to be enrolled in total."

Answered by AI

What other investigations have utilized Gallium Dotatate to test its effects?

"Presently, 15 clinical trials are researching Gallium Dotatate; none of them have reached Phase 3. While the principal research for this treatment is conducted in Bethesda, Maryland., 47 sites across the US are currently running relevant studies."

Answered by AI

What criteria must be met for individuals to qualify for participation in this clinical trial?

"The requisite qualifications for this research trial involve having a pancreatic diagnosis and being between 19 to 100 years old. Currently, there are 12 participants enrolled in the program."

Answered by AI

Is this clinical trial pioneering any new territory?

"Currently, 15 active research projects utilizing Gallium Dotatate are underway across 19 cities and 13 countries. The first investigation was funded by Ozmosis Research Inc., in 2016 with a cohort of 195 participants who completed the necessary stages for drug approval. Since then, two additional trials have been launched."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Molecular-Guided Surgery for Pancreatic and GI Neuroendocrine Cancers

Sushanth Reddy 2019. "Molecular-Guided Surgery for Pancreatic and GI Neuroendocrine Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03623984.