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18F-FluorApoTrace Imaging for Lymphoma Treatment Response

Phase < 1
Recruiting
Led By Farrokh Dehdashti, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No known hematological disorders
Capable of lying still and supine within the PET/CT scanner for up to 1 hour at a time.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and post-treatment (estimated to be 14 days)
Awards & highlights

Study Summary

This trial is testing a new method to detect a specific form of cell death that leads to clearance of dead cells without causing inflammation or injury to normal adjacent tissues.

Who is the study for?
This trial is for adults over 18 with lymphoma, including Diffuse Large B-Cell and Non-Hodgkin's Lymphoma. Participants should be healthy without blood disorders, able to follow study instructions, lie still in a scanner for up to an hour, and provide informed consent.Check my eligibility
What is being tested?
The trial tests if a tracer called 18F-FluorApoTrace can safely show apoptosis (a form of cell death) in patients undergoing standard lymphoma treatments like R-CHOP or R-EPOCH by targeting caspase-3 activation.See study design
What are the potential side effects?
Specific side effects are not listed but may include reactions related to the PET/CT scanning process or the tracer itself. The safety profile of 18F-FAT will be assessed during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have any blood disorders.
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I can lie still on my back for up to an hour.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and post-treatment (estimated to be 14 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and post-treatment (estimated to be 14 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in maximum standard uptake value (SUV) (Cohort 2 only)
Change in mean standard uptake value (SUV) (Cohort 2 only)
Radiation doses (rems) to critical organs (Cohort 1 only)
+1 more
Secondary outcome measures
Body Weight Changes
Distribution volume ratio (DVR) (Cohort 2 only)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 2b: Newly Diagnosed DLBCL patients being treated with R-CHOPExperimental Treatment1 Intervention
-N=9: 18F-FAT imaging session at baseline and best time point determined from Cohort 2a (2 days post Cycle 1 standard of care therapy)
Group II: Cohort 2a: Newly Diagnosed DLBCL patients being treated with R-CHOPExperimental Treatment1 Intervention
-N= 6 : 18F-FAT imaging session at baseline and Day 2-4 following Cycle 1 standard of care therapy.
Group III: Cohort 1 = Healthy VolunteersExperimental Treatment1 Intervention
Healthy volunteers (N=6, three male, three female) will be recruited to undergo a single 18F-FAT PET/CT imaging session for radiation dosimetry estimates. 18F-FAT administration followed by body imaging at 3 time points 0-60 min = multiple quick body scans 120 min post injection = body scan 240 min post injection = body scan

Find a Location

Who is running the clinical trial?

AbbVieIndustry Sponsor
958 Previous Clinical Trials
502,369 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,936 Previous Clinical Trials
2,299,831 Total Patients Enrolled
Farrokh Dehdashti, M.D.Principal InvestigatorWashington University School of Medicine
7 Previous Clinical Trials
220 Total Patients Enrolled

Media Library

18F-FluorApoTrace Clinical Trial Eligibility Overview. Trial Name: NCT05048732 — Phase < 1
Non-Hodgkin's Lymphoma Research Study Groups: Cohort 2a: Newly Diagnosed DLBCL patients being treated with R-CHOP, Cohort 1 = Healthy Volunteers, Cohort 2b: Newly Diagnosed DLBCL patients being treated with R-CHOP
Non-Hodgkin's Lymphoma Clinical Trial 2023: 18F-FluorApoTrace Highlights & Side Effects. Trial Name: NCT05048732 — Phase < 1
18F-FluorApoTrace 2023 Treatment Timeline for Medical Study. Trial Name: NCT05048732 — Phase < 1

Frequently Asked Questions

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

Are there any available slots for volunteers to partake in this research?

"Affirmative, the details on clinicaltrials.gov indicate that this trial is presently recruiting participants. This research project was initially posted on December 6th 2021 and its data has been recently refreshed as of December 7th 2021. The study requires 21 patients from a single medical centre to participate in it."

Answered by AI

How many subjects have been recruited to take part in this clinical trial?

"Affirmative. Information available on clinicaltrials.gov confirms that this medical trial is currently recruiting participants, with the initial post being made on December 6th 2021 and last updated a day later. 21 volunteers are necessary to be recruited from one particular location."

Answered by AI
~5 spots leftby Jan 2025