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Radiopharmaceutical
Me-4FDG PET/CT Scan for Lung Cancer
Phase 1 & 2
Recruiting
Led By Claudio Scafoglio
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
BENIGN ARM: Lung nodules considered to be clinically benign, according to the Guidelines for Management of Incidental Pulmonary Nodules from the Fleischner Society. Will consider "benign" the nodules with a lung-RADS score of 1-3
CANCER ARM: Pathologically confirmed lung adenocarcinoma. For patients who are surgical candidates, the pathologic report on the surgical specimen will confirm the diagnosis. For patients who are not surgical candidates, the enrollment will be contingent upon a pathologic diagnosis of lung cancer obtained by needle biopsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within one week of experimental pet/ct scan
Awards & highlights
Study Summary
This trial is testing a new PET scan that uses a radioactive glucose tracer to look for early signs of lung cancer.
Who is the study for?
This trial is for adults over 18 with lung nodules seen on CT scans. It's open to those with confirmed lung adenocarcinoma and also to those with nodules considered benign. People can't join if they're taking diabetes medications like SGLT2 inhibitors or metformin, have a diabetes diagnosis, or are pregnant.Check my eligibility
What is being tested?
The study tests a new PET scan using Me-4FDG, a radioactive glucose tracer that helps detect cancer by showing where glucose is absorbed in the body. The goal is to see how well this new method works for early detection of lung cancer compared to current techniques.See study design
What are the potential side effects?
Since the trial involves diagnostic imaging rather than medication, side effects may include discomfort from the PET/CT procedure and exposure to radiation. Allergic reactions or other adverse effects from the tracer are possible but expected to be rare.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung nodules are considered benign with a lung-RADS score of 1-3.
Select...
My lung cancer is confirmed to be adenocarcinoma.
Select...
I am older than 18 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within one week of the experimental pet/ct scan
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within one week of the experimental pet/ct scan
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy of Me-4FDG in diagnosing lung cancer
2-Mercaptoethanol
Optimal combination of sensitivity and specificity
+2 moreSecondary outcome measures
Correlation of Me-4FDG positivity with histopathological features (expression of SGLT2)
Correlation of Me-4FDG positivity with histopathological features (tumor grade)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Diagnostic (Me-4FDG PET/CT)Experimental Treatment4 Interventions
Patients receive Me-4FDG tracer IV and then undergo PET/CT over 15 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography
2008
Completed Phase 2
~2240
Computed Tomography
2017
Completed Phase 2
~2720
Find a Location
Who is running the clinical trial?
Lungevity FoundationUNKNOWN
2 Previous Clinical Trials
124 Total Patients Enrolled
LUNGevity FoundationOTHER
7 Previous Clinical Trials
1,586 Total Patients Enrolled
Jonsson Comprehensive Cancer CenterLead Sponsor
360 Previous Clinical Trials
27,652 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lung nodules are considered benign with a lung-RADS score of 1-3.My lung cancer is confirmed to be adenocarcinoma.You have a lung spot that is at least 1 cm in size seen on a CT scan.I am currently taking SGLT2 inhibitors or metformin.I am older than 18 years.I have been diagnosed with diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Diagnostic (Me-4FDG PET/CT)
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.
Are there any current opportunities for people to join this clinical trial?
"Clinicaltrials.gov states that this medical trial is not presently seeking patients. Initially posted on January 1st 2023 and last modified on October 19th 2022, it appears to be inactive for the moment - however there are still 59 other trials actively recruiting candidates at present."
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