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Clinical Trial · NCT03949517
68-Ga PSMA 11 PET/MRI and 68-Ga RM2 PET/MRI for Evaluation of Prostate Cancer Response to HIFU Therapy
Overview
This study is being conducted to determine whether the combination of imaging agents 68-Ga RM2 and 68-Ga PMSA11 is better at assessing response to high intensity focused ultrasound (HIFU) or high dose rate (HDR) local therapy than standard imaging or biopsy in patients with known prostate cancer.
Sponsor
Stanford University
Phase
Phase 1/2
Contacts
Andrei H Iagaru, MD (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT03949517Drug / Compound
RM2
Isotope(s):
GALLIUM-68
Radioisotope: Ga-68
Theranostic Role: PET Imaging
T1/2 (Half-Life): 68 minutes
Decay Mode: POSITRON β+ (88.9%), GAMMA, ELECTRON CAPTURE (8.7%)
Energy: Beta: max 1.9 MeV Gamma 1.1 MeV, 511 keV
Range: N/A
Decay Daughters: Zn68 (Stable)
Status: FDA Approvals: NETSPOT® (2016), LOCAMETZ® (2022), ILLUCIX® (2021)
Target(s):
- GRPR
Ligand Class: Peptides
Chelator: DOTA
PSMA-11
Isotope(s):
GALLIUM-68
Radioisotope: Ga-68
Theranostic Role: PET Imaging
T1/2 (Half-Life): 68 minutes
Decay Mode: POSITRON β+ (88.9%), GAMMA, ELECTRON CAPTURE (8.7%)
Energy: Beta: max 1.9 MeV Gamma 1.1 MeV, 511 keV
Range: N/A
Decay Daughters: Zn68 (Stable)
Status: FDA Approvals: NETSPOT® (2016), LOCAMETZ® (2022), ILLUCIX® (2021)
Target(s):
- PSMA
Ligand Class: Small Molecules
Chelator: HBED-CC
Eligibility
Inclusion
- Known prostate cancer
- Planned HIFU or HDR local therapy
- Karnofsky performance status of 50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent)
Exclusion
Exclusion criteria not yet provided.
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