Simultaneous Hyperpolarized [1-13C]Pyruvate and 18F-FDG PET/MRS in Cancer Patients

• Status: Enrolling by invitation
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Prospective phase 2a clinical trial to demonstrate proof-of-concept for simultaneous hyperpolarized [1-13C]pyruvate and 18F-FDG for positron emission tomography (PET) and MRS (magnetic resonance spectroscopy) in a PET/MR scanner in patients with cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Treatments: Fluorodeoxyglucose F18

Criteria

Inclusion Criteria:

• Diagnosed with breast cancer or gastro-entero-pancreatic neuroendocrine neoplasms (GEP-NEN) grades G1, G2 or G3

• Measurable solid tumor of at least 1.5 cm

• Capable of understanding the patient information in Danish and giving full informed consent

Exclusion Criteria:

• Pregnancy

• Breast-feeding

• Weighs above 140 kg and/or with abdominal circumference exceeding the gantry of the PET/MR coil (120 cm)

• History of allergic reaction attributable to compounds of similar chemical or biologic composition to 18F-FDG or pyruvate

• Patients who are unable to lie in the MR scanner for up to 90 minutes

• Pace-maker

• Metallic implantations within the past 6 weeks

• Non-MR compatible implants

• Claustrophobia

• Participants who have not fasted for a minimum of 4 hours prior to the planned scan time