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PYLARIFY PET-CT Imaging for Cancer

Phase 1
Recruiting
Led By Yang Lu, MD, PHD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years. Children are excluded from this study due to lack of dosing or adverse event data in this population.
ECOG performance status ≤2 (Karnofsky ≥60%).
Must not have
Unable to lie flat during or tolerate PET-CT.
Patients with other types of pancreatic, hepatic or breast neoplasms.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial will test if the drug piflufolastat F18 can help produce clearer images in scans for breast, liver, and pancreatic cancers.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Specific side effects for piflufolastat F18 aren't established but could include reactions similar to other PSMA PET radiopharmaceuticals like nausea or discomfort from the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
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My cancer is confirmed as pancreatic, liver, or invasive lobular breast cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot lie flat for scans due to discomfort or other reasons.
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I have a type of cancer that is not pancreatic, liver, or breast cancer.

Timeline

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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Piflufolastat F18Experimental Treatment1 Intervention
Piflufolastat F18 will first be given by vein over about 5 seconds.

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,065 Previous Clinical Trials
1,802,188 Total Patients Enrolled
Lantheus Medical ImagingIndustry Sponsor
56 Previous Clinical Trials
4,332,640 Total Patients Enrolled
Yang Lu, MD, PHDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Piflufolastat F18 Clinical Trial Eligibility Overview. Trial Name: NCT05394259 — Phase 1
Pancreatic Cancer Research Study Groups: Piflufolastat F18
Pancreatic Cancer Clinical Trial 2023: Piflufolastat F18 Highlights & Side Effects. Trial Name: NCT05394259 — Phase 1
Piflufolastat F18 2023 Treatment Timeline for Medical Study. Trial Name: NCT05394259 — Phase 1
~1 spots leftby Jan 2025
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