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New treatment option for Pancreatic Cancer
Official title A Pilot Study to Assess the Clinical Utility of PYLARIFY PET-CT for Detecting Metastasis in Pancreatic Cancer, Hepatocellular Carcinoma and Breast Cancer
ClinicalTrials.gov ID: NCT05394259
What this study is testing
What is Piflufolastat F18?
Piflufolastat F18 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pancreatic cancer.
Also referred to as PYLARIFY.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To learn if piflufolastat F18 can be used in imaging scans for patients with breast cancer, HCC, or pancreatic cancer
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years. Because no dosing or adverse event data are currently available on the use of PYLARIFY in patients \<18 years of age, children are...
- ECOG performance status ≤2 (Karnofsky ≥60%,).
- Subject or subject's Legally Authorized Representative (LAR) is able to understand, willing and able to provide written informed consent.
- Patients must have histologically or cytologically confirmed pancreatic ductal adenocarcinoma, HCC and invasive lobular carcinoma
- Patients with either: a) clinical or radiological (SoC CT, or MRI or FDG PET-CT tests) suspicion of metastatic disease; or b) proven metastatic...
You likely can't join if
- Pregnant or breastfeeding during participation in the study are excluded because: There is no information on the risk of adverse developmental...
- History of allergic reactions to PSMA PET radiopharmaceuticals.
- Patients with psychiatric illness/social situations that would limit compliance with study requirements.
- Unable to lie flat during or tolerate PET-CT
- Patients who have had chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to PYLARIFY (piflufolastat F18) injection.
- Contraindications to PYLARIFY Injection have not been established in humans. None are known or have been observed in nonclinical or clinical studies...
See the full eligibility criteria
- Age ≥18 years. Because no dosing or adverse event data are currently available on the use of PYLARIFY in patients \<18 years of age, children are excluded from this study.
- ECOG performance status ≤2 (Karnofsky ≥60%,).
- Subject or subject's Legally Authorized Representative (LAR) is able to understand, willing and able to provide written informed consent.
- Patients must have histologically or cytologically confirmed pancreatic ductal adenocarcinoma, HCC and invasive lobular carcinoma
- Patients with either: a) clinical or radiological (SoC CT, or MRI or FDG PET-CT tests) suspicion of metastatic disease; or b) proven metastatic disease but in whom there is suspicion of an even greater tumor burden that...
- Patients with at least one measurable lesion on SoC imaging modality (CT, or MRI, or FDG PET-CT). Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one...
- Ability and willingness to undergo biopsy if needed per standard of care for possible metastasis which could change therapy approach. Subject requires further confirmatory diagnostic procedures to confirm PYLARIFY...
- Either: a) treatment naïve; or b) in active treatment but with suboptimal clinical outcome/response, as determined by treating physicians, and with SoC plan to further biopsy suspected metastatic lesions, PYLARIFY...
- Estimated life expectancy of at least 3 months as determined by the Investigator or treating physician.
- Pregnant or breastfeeding during participation in the study are excluded because: There is no information on the risk of adverse developmental outcomes in pregnant women or animals with the use of piflufolastat F18. All...
- History of allergic reactions to PSMA PET radiopharmaceuticals.
- Patients with psychiatric illness/social situations that would limit compliance with study requirements.
- Unable to lie flat during or tolerate PET-CT
- Patients who have had chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to PYLARIFY (piflufolastat F18) injection.
- Contraindications to PYLARIFY Injection have not been established in humans. None are known or have been observed in nonclinical or clinical studies performed to date. As indicated FDA product labels: Androgen...
- people with any medical condition or circumstance that the investigator believes may compromise the safety or compliance of the subject to produce reliable data or completing the study.
- Patients with other types of pancreatic, hepatic or breast neoplasms will be excluded
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.