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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%).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Accuracy is defined as the number of concordant cases between PYLARIFY PET-CT and the gold standard truth divided by the total sample size.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Piflufolastat F18Experimental Treatment1 Intervention
Piflufolastat F18 will first be given by vein over about 5 seconds.
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,263 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had allergic reactions to PSMA PET radiopharmaceuticals in the past.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.I am willing to have a biopsy if my doctor thinks it's necessary.I (or my legal representative) can understand and agree to the study's terms.I am 18 years old or older.I haven't had chemotherapy, immunotherapy, or radiotherapy in the last 4 weeks.I cannot lie flat for scans due to discomfort or other reasons.I can take care of myself but might not be able to do heavy physical work.I have no known allergies or adverse reactions to PYLARIFY.You have at least one spot that can be measured on a CT scan, MRI, or PET-CT scan.I have a type of cancer that is not pancreatic, liver, or breast cancer.My cancer is confirmed as pancreatic, liver, or invasive lobular breast cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Piflufolastat F18
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants has this clinical trial recruited thus far?
"Indeed, the records hosted on clinicaltrials.gov testify that this medical trial is currently recruiting participants. It was unveiled on October 28th 2022 and updated lastly on November 28th of the same year. 36 individuals are expected to join from a single site."
Answered by AI
Are there any recruitment opportunities for participants in this experiment?
"Affirmative. Clinicaltrials.gov data affirms that this medical experiment, which was initially posted on October 28th 2022, is actively seeking participants. Approximately 36 patients are required to be recruited from a single trial site."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
MD Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
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