[18F]PARPi Imaging for Brain Cancer

Overseen By Mark Dunphy, DO

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Pregnancy, Breast-feeding, MRI contraindication

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for imaging brain tumors using a special substance called [18F]PARPi (a radiotracer) and advanced imaging scans like PET and MRI. The goal is to determine how effectively these scans can reveal brain cancer and aid doctors in understanding the condition. The trial seeks participants with brain tumors or those who might have a new or recurring tumor showing growth in recent scans. Participants must have at least one brain lesion that is 1.5 cm in diameter or larger and be scheduled for treatment at MSK. As an Early Phase 1 trial, this research aims to understand how this new imaging method works in people, offering participants the chance to contribute to groundbreaking advancements in brain cancer diagnostics.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this method is safe for brain cancer imaging?

Research shows that [18F]PARPi, a new imaging method, is promising in early studies. This method has helped visualize brain tumors more clearly using PET (positron emission tomography) and MRI (magnetic resonance imaging) scans. Early results are encouraging, with [18F]PARPi showing strong presence in active brain cancers and low presence in areas affected by past treatments. This suggests it can help doctors distinguish between new tumor growth and changes from earlier treatments.

Since this trial is in a very early stage, it primarily focuses on how the method works in the body and its overall safety. Researchers are still learning about how well people tolerate [18F]PARPi. However, testing in humans at this stage suggests some confidence in its basic safety. As with any new method, risks may exist, and the research team will closely monitor for any side effects as the trial progresses. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about [18F]PARPi for brain tumors because it offers a novel imaging method that could improve diagnosis and treatment planning. Unlike traditional imaging techniques, [18F]PARPi is a radiotracer that specifically targets PARP enzymes, which are often more active in cancer cells. This means that [18F]PARPi might provide clearer images of brain tumors, helping doctors to differentiate between cancerous and non-cancerous tissue more accurately. By combining this with PET/MR imaging, the hope is for more precise detection and monitoring of brain tumors, potentially leading to more tailored and effective treatment strategies.

What evidence suggests that [18F]PARPi with PET/MR is effective for brain cancer?

Research has shown that [18F]PARPi holds promise for brain cancer imaging. In this trial, participants with brain cancer will undergo [18F]PARPi-PET/MR scans. Studies have found that these scans can differentiate between active brain cancer and treatment-induced changes. In early tests with people, [18F]PARPi successfully targeted cancer sites in brain tumor patients. It also outperformed other imaging agents in distinguishing between radiation damage and recurring tumors. These early results suggest that [18F]PARPi can help doctors better understand and treat brain cancer by providing clearer images. ^{1 2 3 4 6}

Who Is on the Research Team?

Robert Young, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Patients with new or suspected recurrent brain tumors (including suspected recurrent brain tumors showing growth from any preceding scan)

Minimum at least one brain lesion size >/= 1.5cm diameter

Scheduled to undergo treatment at MSK

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo PET/MR imaging to collect data on [18F]PARPi uptake in brain tumors

Up to 24 weeks

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• [18F]PARPi
• PET/MR with [18F]PARPi

How Is the Trial Designed?

Group I: Participants with Brain Cancer Experimental Treatment 2 Interventions

Participants with new or suspected recurrent brain tumors

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7758909/

Preclinical and first-in-human-brain-cancer applications ...

We demonstrate that [18F]PARPi PET/MR can differentiate active brain cancer from treatment-related changes with encouraging results. [18F]PARPi uptake is ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04173104

PET and MRI Imaging of Brain Tumors Using [18F]PARPi

An entry on ClinicalTrials.gov that contains a summary of a clinical study's protocol information, including the recruitment status; eligibility criteria; ...

3.

medrxiv.org

medrxiv.org/content/10.1101/2020.07.13.20141036.full

Preclinical and first-in-human-brain-cancer applications of [ ...

This study describes the cancer-related localization of [18F]PARPi in mouse glioma models as well as in first-in-human-brain-cancer patients.

4.

ejnmmires.springeropen.com

ejnmmires.springeropen.com/counter/pdf/10.1186/s13550-018-0399-z.pdf

Discriminating radiation injury from recurrent tumor with

Conclusions: A murine model of radiation necrosis does not demonstrate [18F]PARPi avidity, and [18F]PARPi-PET is better than [18F]FET-PET in distinguishing ...

5.

jnm.snmjournals.org

jnm.snmjournals.org/content/60/4/504

PET Imaging of PARP Expression Using 18F-Olaparib

We show that 18 F-olaparib has great potential for noninvasive tumor imaging and monitoring of radiation damage.

6.

cancer.gov

cancer.gov/clinicaltrials/NCI-2019-08134

[18F]PARPi PET/MRI for the Imaging of Patients with New ...

This trial studies how well [18F]PARPi positron emission tomography (PET)/magnetic resonance imaging (MRI) works in imaging patients with brain tumors that ...