Using advanced MRI to assess treatment response in pancreatic cancer
Translating Hyperpolarized 13C MRI as a Novel Tool to Predict Treatment Response in Pancreatic Cancer
This study is testing a new MRI technique to see if it can better predict how well treatment works for people with pancreatic cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT06600906 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of hyperpolarized carbon-13 pyruvate magnetic resonance imaging (MRI) in predicting treatment response in patients with pancreatic ductal adenocarcinoma (PDA), including both locally advanced and metastatic cases. The study aims to measure changes in tumor metabolism using this experimental imaging technique before and after treatment initiation. By comparing these metabolic changes to standard imaging results, researchers hope to determine if this new approach provides better predictive value for treatment outcomes. The study includes various cohorts to assess different aspects of tumor response and metabolism over time.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with histologically confirmed pancreatic ductal adenocarcinoma that is either locally advanced or metastatic.
Not a fit: Patients who are unable to undergo MRI due to contraindications or those with poorly controlled hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved methods for predicting treatment responses in pancreatic cancer, potentially guiding more effective treatment strategies.
How similar studies have performed: While the use of hyperpolarized MRI is a novel approach, similar imaging techniques have shown promise in other cancer types, suggesting potential for success in this context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Francisco, California
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Zhen Wang, MD — University of California, San Francisco
- Study coordinator: Louise Magat
- Email: Louise.Magat@ucsf.edu
- Phone: (415) 502-1822
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.