Hyperpolarized 13C MRI to Predict Response in Pancreatic Cancer

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Sep 14, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new type of MRI scan called hyperpolarized carbon-13 pyruvate MRI to see how well it can predict the response of pancreatic cancer to treatment. This research focuses on patients with pancreatic ductal adenocarcinoma (PDA) that is either locally advanced (meaning it has spread to nearby tissues or lymph nodes) or metastatic (meaning it has spread to other parts of the body). The goal is to find out if this experimental scan can provide better information about how the cancer is reacting to therapy compared to standard MRI scans that use traditional contrast agents.

To participate in this study, individuals must be at least 18 years old and have a confirmed diagnosis of pancreatic ductal adenocarcinoma that is locally advanced or metastatic. They should have at least one measurable tumor in the abdomen and a good overall health status. Participants will undergo the new MRI scan and will be closely monitored throughout the study. It's important to note that certain people, including those with specific health conditions or who are pregnant or breastfeeding, may not be eligible for this trial. This study is currently recruiting participants, and those interested should discuss it with their healthcare team.

Gender

ALL

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