Pancreatic CancerPhase 1NCT05394259
A Pilot Study to Assess the Clinical Utility of PYLARIFY PET-CT for Detecting Metastasis in Pancreatic Cancer, Hepatocellular Carcinoma and Breast Cancer
A Phase 1 study testing Piflufolastat F18 in people with Pancreatic Cancer and Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn if piflufolastat F18 can be used in imaging scans for patients with breast cancer, HCC, or pancreatic cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Breast Cancer, Hepatocellular Carcinoma
- What is being tested?
- Piflufolastat F18
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2022to 2 Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 could change therapy approach.
- Patients with at least one measurable lesion on SoC imaging modality (CT, or MRI, or FDG PET-CT).
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- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam.
- 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.
- 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.
- Estimated life expectancy of at least 3 months as determined by the Investigator or treating physician.
Who cannot join
- 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.
- 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 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.
- 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.
- Patients with other types of pancreatic, hepatic or breast neoplasms will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
To learn if piflufolastat F18 can be used in imaging scans for patients with breast cancer, HCC, or pancreatic cancer
Read the detailed description
Primary Objective:
- To assess the diagnosis accuracy of PYLARIFY (piflufolastat F18 ) PET-CT for imaging patients with suspected metastatic pancreatic cancer, hepatocellular carcinoma (HCC) and breast cancer. Accuracy is defined as the number of concordant cases between PYLARIFY PET-CT and the gold standard truth divided by the total sample size
Secondary Objectives:
- To assess diagnosis accuracy of PYLARIFY (piflufolastat F18 ) PET-CT for imaging patients with suspected metastatic pancreatic cancer, hepatocellular carcinoma (HCC) and breast cancer by additional accuracy measures including sensitivity, specificity, negative predictive value and positive predictive value.
- To evaluate the added clinical usefulness of PYLARIFY (piflufolastat F18) PET-CT for imaging patients with suspected metastatic pancreatic cancer, HCC and breast cancer.
- Conditions
- Pancreatic Cancer, Breast Cancer, Hepatocellular Carcinoma
- Being tested
- Piflufolastat F18
- Medical subject headings
- Pancreatic Neoplasms, Breast Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piflufolastat F18Drug
Also called PYLARIFY
Given by vein (IV)
| Study group | Role | What they receive |
|---|---|---|
| Piflufolastat F18 | Experimental | Piflufolastat F18 will first be given by vein over about 5 seconds. Receives: Drug: Piflufolastat F18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy is defined as the number of concordant cases between PYLARIFY PET-CT and the gold standard truth divided by the total sample size.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start28 Oct 2022
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Lantheus Medical Imaging
- Responsible party
- Sponsor
- Investigators
- Yang Lu, MD, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05394259
- Sponsor's protocol ID
- 2021-1031
- Other IDs
- NCI-2022-04401
- Status last verified
- Aug 2026
- First submitted
- 16 May 2022
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- 2021-1031
- Conditions
- Pancreatic Cancer, Breast Cancer, Hepatocellular Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Lantheus Medical Imaging
- Study start
- 28 Oct 2022 (actual)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To learn if piflufolastat F18 can be used in imaging scans for patients with breast cancer, HCC, or pancreatic cancer
Detailed description
Primary Objective:
- To assess the diagnosis accuracy of PYLARIFY (piflufolastat F18 ) PET-CT for imaging patients with suspected metastatic pancreatic cancer, hepatocellular carcinoma (HCC) and breast cancer. Accuracy is defined as the number of concordant cases between PYLARIFY PET-CT and the gold standard truth divided by the total sample size
Secondary Objectives:
- To assess diagnosis accuracy of PYLARIFY (piflufolastat F18 ) PET-CT for imaging patients with suspected metastatic pancreatic cancer, hepatocellular carcinoma (HCC) and breast cancer by additional accuracy measures including sensitivity, specificity, negative predictive value and positive predictive value.
- To evaluate the added clinical usefulness of PYLARIFY (piflufolastat F18) PET-CT for imaging patients with suspected metastatic pancreatic cancer, HCC and breast cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Piflufolastat F18 | Experimental | Drug: Piflufolastat F18Piflufolastat F18 will first be given by vein over about 5 seconds. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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 could change therapy approach.
Key exclusion criteria (8 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Piflufolastat F18Also: PYLARIFYGiven by vein (IV) | Drug | Piflufolastat F18 |
Primary outcome
Accuracy is defined as the number of concordant cases between PYLARIFY PET-CT and the gold standard truth divided by the total sample size.
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yang Lu, MD, PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Piflufolastat F18 in people with Pancreatic Cancer and Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy is defined as the number of concordant cases between PYLARIFY PET-CT and the gold standard truth divided by the total sample size. (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.