PYLARIFY PET-CT Imaging for Cancer

Overseen By Yang Lu, MD, PHD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Chemotherapy, Immunotherapy, Radiotherapy, others

Disqualifiers: Pregnancy, Allergic reactions, Psychiatric illness, others

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

Compensation: Varies

Number of Visits: 1

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new imaging agent, piflufolastat F18, can improve scans for patients with certain types of cancer, including breast, liver (HCC), and pancreatic cancers. The goal is to determine if this agent can detect cancer spread more accurately than current methods. The process involves a simple injection followed by a scan. Suitable candidates have confirmed breast, liver, or pancreatic cancer and either suspect or know that their cancer has spread. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new imaging agent.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have had chemotherapy, immunotherapy, or radiotherapy within 4 weeks before the trial, you may not be eligible to participate.

Is there any evidence suggesting that piflufolastat F18 is likely to be safe for humans?

Previous studies have used piflufolastat F18 safely for imaging prostate cancer. As a PET imaging agent, it helps doctors visualize certain proteins in the body through a special scan. Prostate cancer patients have tolerated this treatment well, with most experiencing only mild side effects, such as feeling warm or having a headache. Serious side effects are rare. Although the FDA has approved this treatment for prostate cancer imaging, its safety for other cancers, like breast or pancreatic, remains under investigation. In this early-phase trial, researchers are beginning to explore its safety in these new areas. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Piflufolastat F18 because it represents a novel approach to cancer imaging. Unlike traditional imaging methods which may rely on older tracers, Piflufolastat F18 is a radiotracer that targets prostate-specific membrane antigen (PSMA), offering more precise imaging of certain cancers, particularly prostate cancer. This specificity could potentially enhance the detection and monitoring of cancer, offering clearer insights into the disease's progression and response to treatment. Additionally, it is administered quickly through a simple intravenous injection, making the process less invasive and more efficient for patients.

What evidence suggests that Piflufolastat F18 is effective for imaging breast cancer, HCC, or pancreatic cancer?

Research has shown that piflufolastat F18, which participants in this trial will receive, is a promising imaging tool, particularly for detecting cancer. In studies with prostate cancer patients, it accurately identified cancer. Doctors reported increased confidence in their treatment plans after using piflufolastat F18 scans in 96% of cases. While most research has focused on prostate cancer, this imaging agent could also aid in visualizing other cancers, such as breast, liver, and pancreatic. It targets PSMA, a protein often found in higher amounts on cancer cells, making tumors easier to detect in scans. ^{4 6 7 8 9}

Who Is on the Research Team?

Yang Lu, MD, PHD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

Adults with confirmed pancreatic ductal adenocarcinoma, hepatocellular carcinoma (HCC), or invasive lobular breast cancer who may have metastatic disease. Participants must be able to consent, have a measurable lesion, and an estimated life expectancy of at least 3 months. Pregnant women, those allergic to PSMA PET radiopharmaceuticals, or unable to undergo PET-CT are excluded.

Inclusion Criteria

My cancer may have spread, or there's a chance it has spread more than we thought.

I have not started treatment or my current treatment isn't working well, and I am scheduled for a biopsy.

You must have at least one spot that can be accurately measured to see if the treatment is working.

Exclusion Criteria

You have had allergic reactions to PSMA PET radiopharmaceuticals in the past.

I haven't had chemotherapy, immunotherapy, or radiotherapy in the last 4 weeks.

Pregnant or breastfeeding women.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants receive PYLARIFY (piflufolastat F18) PET-CT scans to assess diagnosis accuracy for detecting metastasis

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Piflufolastat F18

Trial Overview The study is testing the effectiveness of piflufolastat F18 in detecting metastasis through imaging scans in patients with breast cancer, HCC, or pancreatic cancer. It aims to see if this can help assess tumor burden and influence treatment decisions.

How Is the Trial Designed?

Group I: Piflufolastat F18 Experimental Treatment 1 Intervention

Piflufolastat F18 will first be given by vein over about 5 seconds.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Lantheus Medical Imaging

Industry Sponsor

Trials

57

Recruited

4,333,000+

Published Research Related to This Trial

The novel PSMA-targeted PET radiotracer [(18)F]DCFPyL detected 139 sites of metastatic prostate cancer in patients, significantly outperforming conventional imaging modalities (CIM), which only identified 45 lesions.

This study suggests that [(18)F]DCFPyL PET imaging is more effective in identifying metastatic disease, especially in cases where CIM results were negative or equivocal, highlighting its potential as a superior diagnostic tool for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PSMA-Based [(18)F]DCFPyL PET/CT Is Superior to Conventional Imaging for Lesion Detection in Patients with Metastatic Prostate Cancer. Rowe, SP., Macura, KJ., Mena, E., et al.[2022]

The new PET agent 18F-DCFPyL, which targets prostate-specific membrane antigen (PSMA), has shown superior diagnostic accuracy compared to conventional imaging methods for staging and restaging prostate cancer, as demonstrated in the OSPREY and CONDOR clinical trials.

The use of PSMA-PET imaging is expected to significantly enhance prostate cancer management and may lead to new diagnostic and therapeutic opportunities, improving overall patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Piflufolastat F-18 (18F-DCFPyL) for PSMA PET imaging in prostate cancer . Voter, AF., Werner, RA., Pienta, KJ., et al.[2022]

Piflufolastat F 18 (PYLARIFY®) is a newly approved diagnostic imaging agent that targets prostate-specific membrane antigen (PSMA) for use in PET scans, specifically for detecting prostate cancer lesions.

Approved in the USA on May 27, 2021, Piflufolastat F 18 is intended for men with prostate cancer who have suspected metastasis or recurrence, providing a valuable tool for guiding treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Piflufolastat F 18: Diagnostic First Approval. Keam, SJ.[2022]

Piflufolastat F 18 is a highly effective PET radiotracer for prostate cancer diagnosis, providing the highest life-years (6.80) and quality-adjusted life-years (5.33) compared to other imaging options like fluciclovine F 18 and PSMA 11.

In terms of cost-effectiveness, piflufolastat F 18 demonstrated lower incremental cost-effectiveness ratios (ICERs) than its competitors, making it a financially favorable choice for prostate cancer diagnosis in the US healthcare system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness Modeling of Prostate-Specific Membrane Antigen Positron Emission Tomography with Piflufolastat F 18 for the Initial Diagnosis of Patients with Prostate Cancer in the United States. Yee, CW., Harvey, MJ., Xin, Y., et al.[2023]

In a study of 235 patients undergoing F-18 PSMA PET imaging for prostate cancer, 65.5% had PSMA-avid lesions detected, indicating its effectiveness in identifying cancer spread.

The imaging led to changes in treatment plans for 54.5% of patients in the initial staging group and 33.9% in the biochemical recurrence group, demonstrating its significant impact on clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of piflufolastat F-18 PSMA PET imaging on clinical decision-making in prostate cancer across disease states: A retrospective review. Arafa, AT., Jain, A., Skrobanek, P., et al.[2023]

The 18F-labeled PSMA-directed PET agent [18F]DCFPyL (PYLARIFY) has shown significant clinical utility in staging and restaging prostate cancer, supported by major trials like OSPREY and CONDOR.

Following its recent FDA approval, [18F]DCFPyL is expected to see increased adoption for imaging and management of prostate cancer, enhancing image-guided treatment strategies in both the U.S. and Europe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[18F]DCFPyL PET/CT for Imaging of Prostate Cancer. Rowe, SP., Buck, A., Bundschuh, RA., et al.[2022]

In a study of 253 patients with biochemically recurrent hormone-sensitive prostate cancer, 40.7% had a change in treatment management after undergoing 18F-DCFPyL PET/CT imaging, highlighting its significant impact on clinical decision-making.

Positive findings from the 18F-DCFPyL PET/CT scan and positive pathological lymph node status were strong predictors for changing treatment plans, while a positive surgical margin was associated with a lower likelihood of management change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management impact of 18F-DCFPyL PET/CT in hormone-sensitive prostate cancer patients with biochemical recurrence after definitive treatment: a multicenter retrospective study. Meijer, D., van Leeuwen, PJ., Oosterholt, PMJ., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12320564/

Imaging Efficacy of [18F]CTT1057 PET for the Detection of ... Of these, 184 patients received a median of 355 MBq (range, 195–400 MBq) of [18F]CTT1057 and underwent PET/CT 90 min (±30 min) later. Three ...

2. pylarify.com pylarify.com/efficacy-safety/diagnostic-performance

Learn About Diagnostic Performance for PYLARIFY® PYLARIFY is a PSMA-targeted PET imaging agent for prostate cancer. Explore the clinical study results to learn more about the diagnostic performance.

3. jnm.snmjournals.org jnm.snmjournals.org/content/66/supplement_1/251554

18F-Piflufolastat PET/CT in Patients with Biochemically ... Conclusions: PSMA-targeted 18F-piflufolastat PET/CT detected recurrent disease in the prostate and prostate bed with consistent and high PPVs ( ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.5_suppl.41

The role of conventional imaging and piflufolastat F18 in ... Across both cohorts, clinicians rated improvement in treatment planning confidence following 96% of piflufolastat F18 scans. Conclusions: ...

5. asco.org asco.org/abstracts-presentations/ABSTRACT375362

Piflufolastat f 18-PET/CT in patients with prostate cancer Results: 345 men underwent piflufolastat F 18-PET/CT. Cohort B (n = 93evaluable) SUVmax and SUVpeak were significantly higher for biopsy positive (+)(one ...

6. pylarify.com pylarify.com/efficacy-safety/safety

Explore PYLARIFY® Safety Data & Side Effects PYLARIFY is a PSMA-targeted PET imaging agent for prostate cancer. Learn more about PYLARIFY safety data and adverse reactions.

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2021/214793s000lbl.pdf

PYLARIFY® (piflufolastat F 18) injection, for intravenous use Based on the intensity of the signals, PET images obtained using PYLARIFY indicate the presence of PSMA in tissues. ... Each patient received a single PYLARIFY ...

8. mayoclinic.org mayoclinic.org/drugs-supplements/piflufolastat-f-18-intravenous-route/description/drg-20516701

Piflufolastat f 18 (intravenous route) - Side effects & uses Piflufolastat F 18 injection is used with a PET scan (positron ... Safety and efficacy have not been established. Geriatric. Appropriate ...

9. cancer.gov cancer.gov/clinicaltrials/NCI-2022-04401

PYLARIFY PET-CT for Detection of Metastasis in ... The goal of this clinical research study is to learn if piflufolastat F18 can be used in imaging scans for patients with breast, liver, or pancreatic cancer.