NCT06600906 Hyperpolarized 13C MRI to Predict Response in Pancreatic Cancer
| NCT ID | NCT06600906 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Pancreatic Ductal Adenocarcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 70 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2030-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 70 participants in total. It began in 2024-10-01 with a primary completion date of 2030-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study evaluates an investigational scan called hyperpolarized carbon-13 pyruvate magnetic resonance imaging (MRI) in assessing treatment response in patients with pancreatic ductal carcinoma (PDA) that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). MRI is a standard scan that helps doctors see tumors, organs, tissue, and bone. Standard contrast agents (e.g., gadolinium) are sometimes used to help make the scan images brighter, or easier to see. Hyperpolarized carbon-13 pyruvate is an experimental contrast agent that is different from standard MRI contrast in that it provides information on how a tumor processes nutrients. Hyperpolarized carbon-13 pyruvate MRI scans may work better than MRI with standard contrast agents in predicting how PDA tumors respond to treatment.
Eligibility Criteria
Inclusion Criteria: * Participants must be 18 years or older. * Histological or cytological confirmation of pancreatic ductal adenocarcinoma (PDA). * Locally advanced or metastatic disease. * At least one target lesion in the abdomen measuring ≥ 1centimeter (cm), according to RECIST v1.1. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2 (Karnofsky ≥ 50%) * Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or endpoints of this study are eligible. * Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: * Participants unwilling or unable to undergo magnetic resonance (MR) imaging, including patients with contra-indications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips. * Poorly controlled hypertension, defined as either systolic \> 170 or diastolic \> 110. The addition of anti-hypertensives to control blood pressure is allowed for eligibility determination. * Congestive Heart Failure ≥ Class III. * Participants who are pregnant. * Individuals of childbearing potential must agree to undergo a urine pregnancy test prior to participating in the study scans. Pregnant individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn child secondary to administration of HP 13C pyruvate to the study participant. A female is considered to not be of childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if they meet either of the following two criteria: (1) has reached a postmenopausal state (\>= 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and/or bilateral oophorectomy for removal of uterus and/or ovaries). * Participants who are breastfeeding/chestfeeding. Breastfeeding/chestfeeding individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn/nursing child secondary to administration of HP 13C pyruvate to the study participant. Breastfeeding/chestfeeding should be discontinued before administration of HP 13C pyruvate. * Known hypersensitivity to HP 13C pyruvate or any of its excipients. * Participants with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study procedures
Contact & Investigator
Zhen Wang, MD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT06600906 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Ductal Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06600906 currently recruiting?
Yes, NCT06600906 is actively recruiting participants. Contact the research team at Louise.Magat@ucsf.edu for enrollment information.
Where is the NCT06600906 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT06600906 clinical trial?
NCT06600906 is sponsored by University of California, San Francisco. The principal investigator is Zhen Wang, MD at University of California, San Francisco. The trial plans to enroll 70 participants.