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Clear Cell Renal Cell CarcinomaPhase 2/3HARRIERNCT07084909

Piflufolastat F 18 PET/CT in Patients With Suspected, or at High Risk for Metastatic ccRCC

A Phase 2/3 study testing piflufolastat F 18 in people with Clear Cell Renal Cell Carcinoma, run by Lantheus Medical Imaging at 2 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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 the extent of clear cell Renal Carcinoma in patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Clear Cell Renal Cell Carcinoma
What is being tested?
piflufolastat F 18
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesUnited States
Study dates
Nov 2025to Sep 2027
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female patients ≥18 years of age
  • Patients must have the ability to understand and sign an approved informed consent form (ICF)
  • Patients must have the ability to understand and comply with all protocol requirements.
  • Subjects should satisfy the following criteria:
  • 1) For the Phase 2 (dose optimization) portion of the study: ccRCC patients with at least one suspected metastatic lesion identified by conventional imaging scans at the time of enrolling in the study 2) For the Phase 3 portion of the study: Patients must be suspected of having or be at high risk for developing metastatic disease. This patient population is generally defined as one of the following:
  • Newly diagnosed ccRCC patients or post- nephrectomy/post-partial nephrectomy patients with radiographically suspected ccRCC metastatic disease by conventional imaging (CI) planned for biopsy to confirm metastatic disease
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  • T2B-T4, N0, M0 as assessed by conventional imaging (CI) at initial staging pre-nephrectomy/pre-partial nephrectomy
  • Confirmed ccRCC with high risk of metastatic recurrence post nephrectomy pT1b or higher with G3-4 N0( or pNX where clinically N0)M0. Patients must be N0, M0 on the follow up CI not more than 60 days prior to piflufolastat F18 scan
  • Patients with new radiographically suspected oligometastatic ccRCC (up to 5 metastatic lesions at presentation) planned for nephrectomy or biopsy for lesion verification of at least one suspected metastatic lesion
  • 5. Completed staging evaluation with baseline conventional imaging (contrast-enhanced CT or contrast-enhanced MRI of the chest, abdomen, and pelvis, or skull base to mid thigh FDG PET)less than or equal to 60 days prior to piflufolastat F 18 PET/CT (Day 1). If baseline conventional imaging was performed outside of the 60-day window, it can be repeated during the screening period provided that there are at least 24 hours between conventional imaging and piflufolastat F 18 (Day 1). Conventional imaging must be available for central evaluation.
  • 6. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • 7. Patients with life expectancy of at least 6 months as determined by the investigator or treating physician.

Who cannot join

  • Patients administered any high energy (>300 KeV) gamma-emitting radioisotope within five (5) physical half-lives, prior to Day 1.
  • Known hypersensitivity to the components of piflufolastat F 18 or its analogs.
  • Pregnant or breastfeeding females. Pregnancy testing will be performed in potentially childbearing women prior to piflufolastat F 18 administration on Day 1.
  • Prior imaging with girentuximab or any PSMA-PET agent or any non-approved ccRCC imaging agent within the last 3-months prior to piflufolastat F 18 PET/CT.
  • Patients who are in active systemic therapy for metastatic ccRCC prior to piflufolastat F 18 PET/CT. 30-day (12 weeks for immunotherapy) washout period is required from the last dose of systemic therapy to piflufolastat F18 administration.
  • Patients who are expected to receive anti-cancer treatment between baseline conventional imaging, piflufolastat F 18 PET/CT, biopsy, or surgery.
Show all 9Show fewer
  • Evidence of any other active malignancy within the past 3 years, except non-melanoma skin cancer, carcinoma in situ, adequately treated Stage 1 cancer from which the patent is in remission and has been in remission for a minimum of 2 years. Any adjuvant or maintenance systemic chemotherapy must have been completed at least 30 days prior to piflufolastat F 18 PET/CT administration (12-week washout if immunotherapy).
  • Patients with any medical condition or other circumstances that, in the opinion of the investigator, compromise the safety or compliance of the subject to produce reliable data or completing the study.
  • Patients requiring dialysis.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • XCancer

    Omaha, Nebraska, 68130

  • Washington University in St. Louis

    St Louis, Missouri, 63130

Other trials in United States

About this study

Official title: Phase 2/3 Open-Label Multicenter Study to Assess the Diagnostic Performance of Piflufolastat F 18 PET/CT on Intended Clinical Management in Patients With Suspected, or at High Risk for Metastatic ccRCC

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 the extent of clear cell Renal Carcinoma in patients.

The main questions it aims to answer are:

Read more
  • What is the most appropriate dose and scan timing window for piflufolastat F 18 PET/CT for patients with clear cell Renal Cell Carcinoma (ccRCC) with known metastatic disease?
  • Ability of piflufolastat F 18 PET/CT to detect metastatic of lesions ccRCC in patients with suspected metastatic disease and those at high risk for metastatic disease (the cancer has spread beyond the kidney) and impact of the imaging on clinical management of the kidney cancer?

Participants will:

  • Receive a single injection of piflufolastat F 18 injection followed by imaging scans.
  • Be contacted via telephone to ask about any reactions or discomforts they may have after the piflufolastat F 18 injection.
  • May be followed for up to 6 months to collect data about disease progression.
Read the detailed description

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 staging of patients suspected of having, or who are at high risk for, metastatic ccRCC and its impact on intended clinical management.

Being tested
piflufolastat F 18
Keywords
kidney cancer, renal cell carcinoma, clear cell, Piflufolastat F 18, PYLARIFY, imaging, ccRCC, PET/CT
Medical subject headings
Carcinoma, Renal Cell, Kidney Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • piflufolastat F 18Drug

    Also called PYLARIFY

    18F-DCFPyL is a fluorine-18 radiolabeled low molecular weight positron emission tomography (PET) tracer that binds to the extracellular domain of prostate-specific membrane antigen (PSMA) with high affinity.

Study groups in NCT07084909
Study groupRoleWhat they receive
Phase 2 - Dose OptimizationExperimentalThe 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.
Receives: Drug: piflufolastat F 18
Phase 3 - Single-arm ExpansionExperimentalPhase 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.
Receives: Drug: piflufolastat F 18

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 2 Primary Objective - Establishing the optimum dose and timing window of piflufolastat F18 for detection of metastatic disease

    Defining the optimal dose and scan timing window for Piflufolastat F18 PET/CT

    Measured: On Day 1 (day of injection) where 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.

  2. Phase 3 Primary Objective - To assess the diagnostic performance of piflufolastat F 18 PET/CT to determine the presence or absence of metastatic disease in ccRCC patients.

    Sensitivity of piflufolastat F 18 PET/CT at the patient level to determine the presence of metastatic ccRCC relative to the composite truth standard. Specificity of piflufolastat F 18 PET/CT at the patient level to determine the absence of metastatic ccRCC relative to the composite truth standard.

    Measured: From Day 1 (day of injection) where Piflufolastat F18 will be administered to 6 months post-piflufolastat F 18 administration to establish the standard of truth.

Secondary outcomes (3)

  1. Phase 3 -To assess the diagnostic performance of piflufolastat F 18 PET/CT for identifying the presence of metastatic lesions in ccRCC

    Correct localization rate (CLR) at the patient level, defined as the percentage of patients for whom there is a one-to-one correspondence between localization of at least one lesion identified on piflufolastat F 18 PET CT and a composite standard of truth (SOT)

    Measured: From Day 1 (day of injection) where Piflufolastat F18 will be administered to 6 months post-piflufolastat F 18 administration to establish the standard of truth.

  2. Phase 3 - Safety and Tolerability

    Incidence of adverse events (AEs), changes in vital signs, clinical laboratory parameters and concomitant medications.

    Measured: From screening to to 6 months post-piflufolastat F 18 administration

  3. Phase 3 - Assess the impact of piflufolastat F 18 PET/CT on intended and actual patient clinical management

    Change in intended and actual patient clinical management in all patients as assessed by a Medical Management Questionnaire (MMQ)

    Measured: From Day 1 (day of injection) where Piflufolastat F18 will be administered to 6 months post-piflufolastat F 18 administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2025
  2. Study startNov 2025 (estimated)
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Why it stopped: Operational challenges in patient enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07084909
Sponsor's protocol ID
PYL2302
Acronym
HARRIER
Status last verified
Dec 2025
First submitted
30 May 2025
Last updated
10 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing piflufolastat F 18 in people with Clear Cell Renal Cell Carcinoma, run by Lantheus Medical Imaging at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 2 Primary Objective - Establishing the optimum dose and timing window of piflufolastat F18 for detection of metastatic disease (time frame: On Day 1 (day of injection) where 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07084909.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.

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