RECRUITING

A Pilot Study to Assess the Clinical Utility of PYLARIFY PET-CT for Detecting Metastasis in Pancreatic Cancer, Hepatocellular Carcinoma and Breast Cancer

Conditions

Pancreatic Cancer Breast Cancer Hepatocellular Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To learn if piflufolastat F18 can be used in imaging scans for patients with breast cancer, HCC, or 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

Quick Facts

Study Start:2022-10-28

Study Completion:2025-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05394259

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 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. 2. ECOG performance status ≤2 (Karnofsky ≥60%,). 3. Subject or subject's Legally Authorized Representative (LAR) is able to understand, willing and able to provide written informed consent. 4. Patients must have histologically or cytologically confirmed pancreatic ductal adenocarcinoma, HCC and invasive lobular carcinoma 5. 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 could change therapy approach. 6. Patients with at least one measurable lesion on SoC imaging modality (CT, or MRI, or FDG PET-CT). 7. 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 (piflufolastat F18)-PET-CT findings and is planned for: a) Biopsy as SoC; or b) Clinical follow- up as SoC. 8. 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 (piflufolastat F18) PET- CT can be performed at least 1 day prior to the planned biopsy. 9. Estimated life expectancy of at least 3 months as determined by the Investigator or treating physician.	1. 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 radiopharmaceuticals, including PYLARIFY, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose; There is no information on the presence of piflufolastat F18 in human milk, the effect on the breastfed infant, or the effect on milk production. 2. History of allergic reactions to PSMA PET radiopharmaceuticals. 3. Patients with psychiatric illness/social situations that would limit compliance with study requirements. 4. Unable to lie flat during or tolerate PET-CT 5. Patients who have had chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to PYLARIFY (piflufolastat F18) injection. 6. 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 deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY in prostate cancer. The effect of these therapies on performance of PYLARIFY PET has not been established. 7. Subjects 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. 8. Patients with other types of pancreatic, hepatic or breast neoplasms will be excluded

Inclusion Criteria

Exclusion Criteria

1. 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.
2. ECOG performance status ≤2 (Karnofsky ≥60%,).
3. Subject or subject's Legally Authorized Representative (LAR) is able to understand, willing and able to provide written informed consent.
4. Patients must have histologically or cytologically confirmed pancreatic ductal adenocarcinoma, HCC and invasive lobular carcinoma
5. 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 could change therapy approach.
6. Patients with at least one measurable lesion on SoC imaging modality (CT, or MRI, or FDG PET-CT).
7. 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 (piflufolastat F18)-PET-CT findings and is planned for: a) Biopsy as SoC; or b) Clinical follow- up as SoC.
8. 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 (piflufolastat F18) PET- CT can be performed at least 1 day prior to the planned biopsy.
9. Estimated life expectancy of at least 3 months as determined by the Investigator or treating physician.

1. 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 radiopharmaceuticals, including PYLARIFY, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose; There is no information on the presence of piflufolastat F18 in human milk, the effect on the breastfed infant, or the effect on milk production.
2. History of allergic reactions to PSMA PET radiopharmaceuticals.
3. Patients with psychiatric illness/social situations that would limit compliance with study requirements.
4. Unable to lie flat during or tolerate PET-CT
5. Patients who have had chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to PYLARIFY (piflufolastat F18) injection.
6. 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 deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY in prostate cancer. The effect of these therapies on performance of PYLARIFY PET has not been established.
7. Subjects 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.
8. Patients with other types of pancreatic, hepatic or breast neoplasms will be excluded

Contacts and Locations

Study Contact

Yang Lu, MD, PHD

CONTACT

(713) 792-5768

ylu10@mdanderson.org

Principal Investigator

Yang Lu, MD, PHD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Yang Lu, MD, PHD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-28

Study Completion Date2025-01-01

Study Record Updates

Study Start Date2022-10-28

Study Completion Date2025-01-01

Terms related to this study

Additional Relevant MeSH Terms

Pancreatic Cancer
Breast Cancer
Hepatocellular Carcinoma