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18F-MFBG Imaging for Neuroendocrine Cancer
Phase 1 & 2
Recruiting
Led By Neeta Pandit-Taskar, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing a new tracer to see how it behaves in the body, how it is removed, and how well it shows neuroendocrine tumors.
Who is the study for?
This trial is for patients with certain neuroendocrine tumors, such as paraganglioma and neuroblastoma, who are over 5 years old and can have a PET scan without sedation. They must show signs of the tumor on a specific type of scan (MIBG) and not have severe organ damage or other serious illnesses.Check my eligibility
What is being tested?
Researchers are testing a new imaging agent called 18F-MFBG to see how it distributes in the body, its elimination process, and if it's effective at showing neuroendocrine tumors on PET scans. Participants will undergo PET imaging and blood tests.See study design
What are the potential side effects?
Since this trial focuses on imaging rather than drug treatment, side effects may be minimal but could include discomfort from injection or reactions related to lying still during the PET scan procedure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
dosimetry of 18F MFBG
radioactivity
Secondary outcome measures
18 F-MFBG imaging PET/CT to target known sites of disease
Trial Design
1Treatment groups
Experimental Treatment
Group I: pts with primary or metastatic neuroendocrine tumorsExperimental Treatment3 Interventions
For phase I, a single dose of 18F-MFBG will be injected intravenously in patients. For all patients, pharmacokinetics and bio distribution will be evaluated using non invasive PET scanning and blood assays at multiple time points post injection. In the expansion phase, a single dose of 18F-MFBG will be injected intravenously followed by a single time point imaging using PET MR scanner or PET/CT. In expansion cohort, an additional 50 patients with NB will be imaged. Patients will receive a single dose of 18F-MFBG intravenously, followed by a whole body PET scan on PET/CT or PET/CT scanner at 60-90 minutes post injection. Patients who show lesion detection by MFBG may be eligible for repeat imaging scan with 18 F- MFBG, at the discretion of PI or study investigator(s). All parameters and technical details of scanning will be as per the study and first imaging.
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,556 Total Patients Enrolled
12 Trials studying Neuroendocrine Tumors
423 Patients Enrolled for Neuroendocrine Tumors
Neeta Pandit-Taskar, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
9 Previous Clinical Trials
278 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: pts with primary or metastatic neuroendocrine tumors
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the approximate sample size of participants in this experiment?
"Affirmative. The information posted on clinicaltrials.gov indicates that this research endeavour is open to recruitment and has been since its initial posting date of January 1st 2015. As of now, 66 participants are sought at a single location."
Answered by AI
Is this trial actively seeking participants at the moment?
"This research endeavour is still open to patient recruitment, with the information on clinicaltrials.gov being last revised in March 2022 since its initial posting in January 2015."
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