Phase 1 Pancreatic Cancer Trial, Recruiting NCT05394259 Sponsor: M.D. Anderson Cancer Center Condition: Pancreatic Cancer
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Phase 1 Pancreatic Cancer Trial, Recruiting

NCT05394259
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 or older (children are not included in this trial because safety information for that age group is not yet available).
  • People whose general health and ability to carry out daily activities meets a minimum functional level, as assessed by their doctor (confirm with trial site).
  • People, or their legally authorised representative, who are able to understand the study and are willing to provide written consent to participate.
  • People who have been diagnosed with one of three specific cancer types through tissue or cell testing: pancreatic ductal adenocarcinoma, hepatocellular carcinoma (HCC), or invasive lobular carcinoma (a type of breast cancer).
  • People who either have a suspected spread of cancer to other parts of the body based on scans or clinical assessment, or who have a confirmed spread but where doctors suspect the cancer may be more widespread than currently known, which could change the treatment plan.
  • People who have at least one tumour or lesion that is large enough to be clearly measured on standard medical imaging (such as CT, MRI, or FDG PET-CT scans), meeting specific size thresholds depending on the type of scan used (confirm with trial site).
  • People who are willing and able to undergo a biopsy if required as part of their standard care, to confirm findings from the PYLARIFY PET-CT scan, or who are planned for clinical follow-up instead.
  • People who are either about to begin cancer treatment for the first time, or who are currently receiving treatment but are not responding as well as hoped, and whose doctor is planning a biopsy of a suspected area of spread — with the PYLARIFY PET-CT scan to be done at least one day before that biopsy.
  • People with a life expectancy of at least three months, as determined by the treating doctor or investigator.

Who may not be able to join:

  • People who are pregnant or breastfeeding, as there is currently no safety information available about the effects of the scan agent (piflufolastat F18) on unborn babies, infants, or milk production.
  • People who have had an allergic reaction to PSMA PET scan agents in the past.
  • People whose mental health conditions or personal circumstances may make it difficult to follow the study requirements.
  • People who are unable to lie flat or tolerate a PET-CT scan.
  • People who have received chemotherapy, immunotherapy, or radiotherapy within the four weeks before receiving the PYLARIFY scan agent.
  • People who are receiving certain hormone-related therapies that target the androgen pathway (such as androgen deprivation therapy or androgen receptor blockers), as these may affect how the scan agent behaves — the impact on scan accuracy has not yet been established (confirm with trial site).
  • People with any medical condition or circumstance that the investigator believes could affect their safety or the reliability of the study results.
  • People diagnosed with other types of pancreatic, liver, or breast cancers that are not the three specific types listed in the inclusion criteria.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Yang Lu, MD, PHD, M.D. Anderson Cancer Center

Phone: (713) 792-5768

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Registry
ClinicalTrials.gov
Start date
28 October 2022
Est. completion
2 February 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Accuracy is defined as the number of concordant cases between PYLARIFY PET-CT and the gold standard truth divided by the total sample size.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov