Piflufolastat F 18 PET/CT for Kidney Cancer

(HARRIER Trial)

Recruiting at 1 trial location

Overseen By Vicki White, Lantheus Clinical Trial Lead

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Lantheus Medical Imaging

Must not be taking: Immunotherapy, Systemic therapy

Disqualifiers: Pregnancy, Dialysis, Active malignancy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

286 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new imaging technique called piflufolastat F 18 PET/CT to improve the diagnosis of kidney cancer, specifically clear cell Renal Cell Carcinoma (ccRCC). Researchers aim to determine the optimal dose and timing for the scan and assess its effectiveness in detecting cancer that has spread beyond the kidney. This trial is suitable for individuals with ccRCC who have suspected or known metastatic cancer, or those at high risk, such as patients who have recently undergone kidney surgery and are concerned about cancer spreading. Participants will receive an injection, followed by scans, and will be monitored for any reactions or disease progression. As a Phase 2 trial, this research measures the effectiveness of the imaging technique in an initial, smaller group, offering participants an opportunity to contribute to advancements in cancer diagnosis.

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

Yes, if you are on active systemic therapy for metastatic kidney cancer, you will need to stop it and wait for a 30-day period (or 12 weeks if it's immunotherapy) before participating in the trial.

What prior data suggests that the piflufolastat F 18 PET/CT imaging technique is safe for diagnosing kidney cancer?

Research has shown that piflufolastat F 18 is generally safe for use in PET scans. Studies have used this imaging agent to help detect and understand kidney cancer. The FDA has not requested additional safety tests for this agent, indicating it is usually well-tolerated by patients.

Piflufolastat F 18 attaches to a protein often found on cancer cells, aiding doctors in locating cancer within the body. While further testing continues, previous studies have not raised new safety concerns, which is reassuring. Participants in this trial will have their health monitored closely to ensure safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for kidney cancer, which typically include surgery, targeted therapies, and immunotherapy, Piflufolastat F 18 offers a unique and non-invasive imaging approach. Researchers are excited because this treatment uses a radiotracer that targets specific cancer cells, allowing for highly precise PET/CT scans. This precision helps in detecting metastatic lesions more accurately and could potentially lead to better treatment planning and outcomes for patients. Additionally, Piflufolastat F 18's ability to provide clear imaging in a short time frame is a significant advantage over traditional imaging methods.

What evidence suggests that this imaging technique is effective for diagnosing kidney cancer?

Research has shown that piflufolastat F 18 PET/CT scans are promising for detecting kidney cancer that has spread beyond the kidney. This trial includes a Phase 2 dose optimization arm to determine the optimal dose and scan timing window for piflufolastat F 18 PET/CT. Following this, a Phase 3 single-arm expansion will further evaluate its effectiveness. This imaging method helps doctors identify where the cancer has spread, allowing for more effective treatment planning. While specific data on piflufolastat F 18 is still being collected, similar PET/CT scans have successfully detected cancer in other types. They excel at identifying cancerous areas that other scans might miss, enabling doctors to make better decisions about cancer management. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with clear cell Renal Cell Carcinoma (ccRCC), either newly diagnosed or post-surgery with suspected metastases. Participants should be able to follow the study plan, have a life expectancy of at least 6 months, and an ECOG status of 0-2, indicating they are fully active or ambulatory.

Inclusion Criteria

My doctor believes I have at least 6 months to live.

I can take care of myself and am up and about more than half of my waking hours.

I can understand and sign a consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Optimization

Phase 2 involves dose optimization to define the optimal dose and scan timing window for piflufolastat F18 PET/CT in 6-12 patients.

1 day

1 visit (in-person)

Single-arm Expansion

Phase 3 involves assessing the diagnostic performance of piflufolastat F 18 PET/CT in 274 patients.

6 months

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and clinical management impact.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Piflufolastat F 18

Trial Overview The trial tests piflufolastat F 18 PET/CT scans in diagnosing and assessing the spread of ccRCC. It will determine the best dose and timing for the scan and evaluate its ability to detect metastatic lesions, potentially influencing patient management.

How Is the Trial Designed?

Group I: Phase 3 - Single-arm Expansion Experimental Treatment 1 Intervention

Phase 3 will commence once the optimal dose and optimal timing window from Phase 2, dose optimization, are determined. Phase 3 will be a single-arm study that will enroll 274 patients with radiographically suspected metastatic disease by conventional imaging or at high risk for metastatic ccRCC at the time of enrollment.

Group II: Phase 2 - Dose Optimization Experimental Treatment 1 Intervention

The dose-optimization, or Phase 2, part of the study will enroll 6-12 ccRCC patients, with at least one metastatic lesion identified by conventional imaging at the time of enrollment, to define the optimal dose and scan timing window for piflufolastat F18 PET/CT. Piflufolastat F18 will be administered at a target dose of 9 mCi \[+/-1 mCi\]) after which patients will be scanned at 60-90 minutes and again at 3-4 hours.

Who Is Running the Clinical Trial?

Lantheus Medical Imaging

Lead Sponsor

Trials

57

Recruited

4,333,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07084909

Study Details | NCT07084909 | Piflufolastat F 18 PET/CT in ... This is an adaptive Phase 2/3, open-label, multi-center, single-arm study designed to evaluate diagnostic performance of piflufolastat F 18 PET/CT in the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9585999/

Prognostic Significance of 18F-FDG PET/CT Imaging in ... The patients' 1-year, 3-year, and 5-year OS rates were 71%, 61%, and 57%, respectively. The highest action of SUVmax-T for estimating OS was a cut-off level of ...

3. cancer.gov cancer.gov/clinicaltrials/NCI-2025-07097

Piflufolastat F 18 PET/CT in Patients With Suspected, or at ... This study is being conducted to test whether an imaging technique called a "piflufolastat F 18 PET/CT" imaging scan can be used to diagnose and describe ...

4. ascopubs.org ascopubs.org/doi/10.1200/EDBK_438658

Emerging Novel Functional Imaging and Immunotherapy in ... This review summarizes the recent developments of functional imaging and immunotherapy strategies in RCC, and the evidence supports treatment sequencing.

5. jnm.snmjournals.org jnm.snmjournals.org/content/66/2/230

Diuresis During 18F-Flotufolastat (rhPSMA-7.3) PET/CT ... A strategy with 18 F-flotufolastat PET/CT and concordant low-dose furosemide further reduces urinary bladder intensity and increases local recurrence detection.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9857064/

The Emerging Role of PET/CT with PSMA-Targeting ... PSMA-targeted PET/CT seems promising in detecting ccRCC lesions as well as in discriminating the presence of aggressive phenotypes.

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2021/214793Orig1s000MultidisciplineR.pdf

214793Orig1s000 - accessdata.fda.gov In summary, no additional nonclinical studies are necessary to support the safety of piflufolastat F 18 for PET imaging of patients with ...