What side effects are associated with this type of intervention?

Common treatments for cancer, particularly those involving PARP inhibitors and PET imaging, have several known side effects. PARP inhibitors, used for cancers with specific genetic mutations, often cause nausea, fatigue, anemia, thrombocytopenia, and neutropenia. PET imaging, while generally safe, involves low-level radiation exposure, which carries a minimal risk of radiation-induced effects. Combining these treatments may result in cumulative side effects, including gastrointestinal disturbances, hematologic toxicities, and general fatigue.

What prior FDA approvals exist?

The FDA has approved several PARP inhibitors for the treatment of cancer, which are relevant to the investigational use of [18F]FluorThanatrace ([18F]FTT) for imaging PARP-1 activity. Notable PARP inhibitors include olaparib, rucaparib, and niraparib, which are used in the treatment of ovarian, breast, and prostate cancers. These drugs work by inhibiting the PARP enzyme, thereby preventing cancer cells from repairing their DNA, leading to cell death. While these treatments do not involve PET imaging, they target the same PARP-1 activity that [18F]FTT aims to image.

What other types of research exist?

Promising alternatives to [18F]FluorThanatrace ([18F]FTT) for imaging cancer in 2024 include radiolabeled fibroblast activation protein inhibitors (FAPI) and [18F]F-FDG. FAPI has shown potential in oncology for its ability to target cancer-associated fibroblasts, while [18F]F-FDG remains a widely used tracer for its effectiveness in detecting metabolic activity in tumors. Additionally, [18F]F-DOPA and [11C]5-hydroxytryptophan are alternative PET tracers that provide valuable diagnostic information in specific cancer types.

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PARP Imaging with [18F]Florathanatrace for Cancer

Q: What is the mechanism of action of this treatment?

PARP inhibitors, such as those targeting PARP-1, work by preventing cancer cells from repairing their DNA, leading to cell death, especially in cells with existing DNA repair deficiencies. This targeted approach can result in better outcomes and fewer side effects for cancer patients. Imaging technologies like PET scans with specific tracers, such as [18F]FluorThanatrace ([18F]FTT), are important as they help monitor the effectiveness of these treatments, enabling more personalized and adaptive treatment plans.

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

Must not have

Unable to lie in the PET/CT scanner for the time required for scanning, up to 1 hour and 15 min at a time and possibly with arms raised above the head for lung imaging.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial uses a special scan and a new radioactive substance to measure an enzyme's activity in cancer cells. It aims to help identify which cancer patients will benefit from specific treatments and ensure they get the right dose.

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.

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.

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 below

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I am healthy, don't smoke, and have no heart or lung issues needing treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I can lie still in a scanner for up to 1 hour and 15 minutes with my arms above my head if needed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial 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.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

PARP inhibitors, such as those targeting PARP-1, work by preventing cancer cells from repairing their DNA, leading to cell death, especially in cells with existing DNA repair deficiencies. This targeted approach can result in better outcomes and fewer side effects for cancer patients. Imaging technologies like PET scans with specific tracers, such as [18F]FluorThanatrace ([18F]FTT), are important as they help monitor the effectiveness of these treatments, enabling more personalized and adaptive treatment plans.

Metformin: (future) best friend of the radiation oncologist?The Mechanism of Action of Regorafenib in Colorectal Cancer: A Guide for the Community Physician.The neoadjuvant treatment of rectal cancer: a review.

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Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,970 Previous Clinical Trials

2,308,573 Total Patients Enrolled

Farrokh L Dehdashti, MDPrincipal InvestigatorWashington University School of Medicine

Media Library

[18F]FluorThanatrace Clinical Trial Eligibility Overview. Trial Name: NCT02469129 — Phase < 1

Cancer Research Study Groups: Dosimetry Studies Arm, Kinetic Studies Arm

Cancer Clinical Trial 2023: [18F]FluorThanatrace Highlights & Side Effects. Trial Name: NCT02469129 — Phase < 1

[18F]FluorThanatrace 2023 Treatment Timeline for Medical Study. Trial Name: NCT02469129 — Phase < 1

~5 spots leftby Sep 2025

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