Status:
ENROLLING_BY_INVITATION
Simultaneous Hyperpolarized [1-13C]Pyruvate and 18F-FDG PET/MRS in Cancer Patients
Lead Sponsor:
Rigshospitalet, Denmark
Conditions:
Breast Cancer
Neuroendocrine Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 spe...
Detailed Description
PET imaging with 18F-FDG is a well established method for non invasively assessing the intracellular glucose accumulation. 18F-FDG PET is used in many applications with diagnosing and staging of patie...
Eligibility Criteria
Inclusion
- Diagnosed with breast cancer, gastro-entero-pancreatic neuroendocrine neoplasms (GEP-NEN) grades G1, G2 or G3, lymphoma or sarcoma
- Measurable solid tumor of at least 1.5 cm
- Capable of understanding the patient information in Danish and giving full informed consent
Exclusion
- 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
Key Trial Info
Start Date :
May 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05396118
Start Date
May 18 2022
End Date
December 1 2024
Last Update
May 14 2024
Active Locations (1)
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1
Rigshospitalet
Copenhagen, Denmark, 2100