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PARP Imaging with [18F]Florathanatrace for Cancer
Phase < 1
Waitlist Available
Led By Farrokh L Dehdashti, MD
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
Healthy volunteers without history of cardiopulmonary conditions requiring any treatment or medical intervention and who are not current smokers (Dosimetry Studies Arm only)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up this is measured from the [18f]ftt pet scan performed at the 1-day study visit.
Awards & highlights
Study Summary
This trial will test if a new PET tracer can image cancer by looking at PARP-1 activity.
Who is the study for?
This trial is for adults with a tumor at least 1 cm in size, or healthy volunteers without cardiopulmonary issues (for different study arms). It's open to those with certain cancers treatable by platinum-based chemo. People can't join if they can't follow the study plan, stay still in a PET/CT scanner, have incompatible implants, non-measurable disease under 1 cm, or conditions like claustrophobia that prevent imaging sessions.Check my eligibility
What is being tested?
[18F]FluorThanatrace ([18F]FTT), a new radioactive tracer for PET scans, is being tested to see if it can effectively image cancer activity related to an enzyme called PARP-1. The trial will assess how well this compound works for visualizing tumors in patients.See study design
What are the potential side effects?
As [18F]FluorThanatrace is a diagnostic agent used during PET imaging rather than a therapeutic drug, typical side effects associated with medications may not apply. However, there could be risks related to radiation exposure and potential allergic reactions to the tracer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am healthy, don't smoke, and have no heart or lung issues needing treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ this is measured from the [18f]ftt pet scan performed at the 1-day study visit.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~this is measured from the [18f]ftt pet scan performed at the 1-day study visit.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Whole body effective dose and doses to critical organs (in rems) of a 10 millicurie (mCi) injection of [18F]FTT
Secondary outcome measures
% positive poly(ADP)ribosylated (PAR) cells by immunohistochemistry
Neoplasms
PARP enzyme activity
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Kinetic Studies ArmExperimental Treatment1 Intervention
An additional 30 participants with cancer will undergo a 1-hour dynamic scan upon injection of [18F]FluorThanatrace to determine the kinetics of the tracer in tumors to correlate with tissue-based markers of PARP activity and to obtain metabolite information to help determine the best quantification approach for the PET images. When possible these subjects will also undergo 18F-FDG imaging for comparison to tumor metabolism
Group II: Dosimetry Studies ArmExperimental Treatment1 Intervention
Twelve participants with cancer and eight healthy volunteers will be recruited first to undergo whole-body PET/CT imaging to determine the whole body dosimetry of [18F]FluorThanatrace.
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Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,933 Previous Clinical Trials
2,299,675 Total Patients Enrolled
Farrokh L Dehdashti, MDPrincipal InvestigatorWashington University School of Medicine
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have a tumor that is at least 1 cm wide, confirmed by a CT scan.I understand and am willing to follow the study's instructions.I am healthy, don't smoke, and have no heart or lung issues needing treatment.You have a history of feeling very uncomfortable or anxious in small spaces, like an MRI machine, or any other condition that would make it difficult for you to complete required imaging sessions.I have been diagnosed with a type of cancer that can be treated with platinum-based chemotherapy.My cancer is less than 1 cm or I am disease-free.I can lie still in a scanner for up to 1 hour and 15 minutes with my arms above my head if needed.
Research Study Groups:
This trial has the following groups:- Group 1: Dosimetry Studies Arm
- Group 2: Kinetic Studies Arm
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 participants being actively sought for this research initiative?
"Per the information on clinicaltrials.gov, this trial is not actively searching for subjects - although it was last updated July 20th 2022. While no longer recruiting patients, there are 485 other trials that have open recruitment windows at present."
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