Your session is about to expire
← Back to Search
18F-4FN PET Imaging Agent for Inflammation Detection
Phase 1
Recruiting
Led By Lesley Flynt, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Normal range standard renal and liver function tests for age: eGFR >= 60 mL/min/1.73 m2, Bilirubin ≤ the upper limit of normal (ULN), Alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ the ULN
Patient >/= 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial is testing a new imaging agent, 18F-4FN, to see if it can detect inflammation in the body. The agent is designed to be attracted to cells that produce high levels of energy, which are typically found at sites of inflammation.
Who is the study for?
Adults diagnosed with endocrine tumors or inflammation due to immune checkpoint inhibitors can join. They must have normal kidney and liver function, not be allergic to the test substance, and weigh less than 400 pounds. Pregnant women, lactating mothers, and children under 18 are excluded.Check my eligibility
What is being tested?
The trial is testing a new PET imaging agent called 18F-4FN that may help visualize inflammation in patients with endocrine neoplasia by highlighting areas where certain immune cells gather.See study design
What are the potential side effects?
Potential side effects of the imaging agent include reactions related to allergies or sensitivities to its components. Since it's a first-in-human study, other specific side effects are still being evaluated.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney and liver function tests are within normal ranges.
Select...
I am 18 years old or older.
Select...
I have a tumor and have had side effects from immune therapy or suspected inflammation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To identify preliminary efficacy signals from PET images that correlate with clinical foci of ICI-related irAE.
Trial Design
1Treatment groups
Experimental Treatment
Group I: 4-[18F]Fluoro-1-NaphtholExperimental Treatment1 Intervention
Participants will receive 1 injection of [18F]4FN
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,380 Total Patients Enrolled
Lesley Flynt, MDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
113 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.You weigh more than 400 pounds or your body mass index (BMI) is too high for the PET/CT scanner to safely support your weight.I am not allergic to [18F]4FN.My kidney and liver function tests are within normal ranges.I am 18 years old or older.I have a tumor and have had side effects from immune therapy or suspected inflammation.If you are pregnant or breastfeeding, you cannot participate in this study because we don't know how the study drug may affect pregnancy. If you are a woman under 60 and can have children, you will need to take a pregnancy test within 24 hours of the PET scan.
Research Study Groups:
This trial has the following groups:- Group 1: 4-[18F]Fluoro-1-Naphthol
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.
How many people are being included in the scope of this clinical trial?
"Affirmative. The information hosted on clinicaltrials.gov verifies that this medical trial, which was first advertised in October of 2022, is currently recruiting patients and requires 10 people at 1 location to participate."
Answered by AI
Is enrollment currently available in this clinical trial?
"Affirmative. Clinicaltrials.gov details that this research initiative, initiated on October 6th 2022 is still open to participant enrolment. The aim is to secure 10 participants from a single medical centre."
Answered by AI
What are the potential detriments associated with 4-[18F]Fluoro-1-Naphthol treatment?
"Due to the preliminary nature of this Phase 1 trial, our team at Power judged 4-[18F]Fluoro-1-Naphthol's safety level as a one on a three point scale. This is because there has only been limited data collected regarding its effectiveness or hazards."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger