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ENROLLING BY INVITATION
NCT05396118
PHASE2

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

Sponsor: Rigshospitalet, Denmark

View on ClinicalTrials.gov

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.

Official title: Phase IIa Clinical Trial: Feasibility Study on Non-Invasive Simultaneous Hyperpolarized [1-13C]Pyruvate Magnetic Resonance Spectroscopy and 18F-FDG PET (hyperPET) for Metabolic Imaging in Patients With Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2022-05-18

Completion Date

2024-12

Last Updated

2024-05-14

Healthy Volunteers

No

Interventions

DRUG

18F-FDG

Injection of 4 MBq/kg of 18F-FDG followed by dynamic positron emission tomography (PET) imaging

DRUG

Injection of hyperpolarized [1-13C]Pyruvate

Injection of one bolus of 0.43 ml/kg of approximately 250 mM hyperpolarized \[1-13C\]Pyruvate followed by magnetic resonance spectroscopy (MRS) / magnetic resonance spectroscopy imaging (MRSI). After a 5-30 min pause, injection of a second bolus of 0.43 ml/kg of approximately 250 mM hyperpolarized \[1-13C\]Pyruvate followed by MRS / MRSI.

PROCEDURE

PET/MR/MRS/MRSI scanning

Regional dynamic PET acquisition for up to 90 minutes following 18F-FDG injection is performed focused on a region-of-interest (ROI). Anatomical magnetic resonance imaging (MRI) is performed in the ROI, including diffusion weighted imaging (DWI) and contrast enhanced imaging (DCE). MRS/MRSI is performed following the injections of hyperpolarized \[1-13C\]Pyruvate.

Locations (1)

Rigshospitalet

Copenhagen, Denmark