Ignite Creation Date:
2024-05-06 @ 4:11 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04904120
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2021-05-03
Brief Title:
Targeted Imaging of Melanoma for Alpha-Particle Radiotherapy
Sponsor:
Perspective Therapeutics
Organization:
Perspective Therapeutics
Study Overview
Official Title:
A Phase 1 Cross-over Biodistribution Study of 203PbVMT01 for Single Photon Emission Computed Tomography SPECT Imaging and 68GaVMT02 for Positron Emission Tomography PET Imaging of Stage IV Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TIMAR1
Brief Summary:
The study hypothesis is that new imaging agents 203PbVMT01 and 68GaVMT02 can be safely used in humans without independent biological effect and can be used to image melanoma tumors expressing the melanocortin sub-type 1 receptor MC1R by SPECTCT and PETCT imaging modalities respectively
Detailed Description:
This is a first-in-human study evaluating the suitability of 203PbVMT01 for SPECTCT imaging and 68GaVMT02 for PETCT imaging of MC1R-expressing metastatic melanoma Study results will provide foundational data to develop imaging and dosing for future therapeutic trials of 212PbVMT01 for the treatment of metastatic melanoma
The study will be a cross-over study with the participants serving as their own comparator Participants with positive FDG-PET scans for stage IV or inoperable stage III metastatic melanoma will undergo SPECTCT scans utilizing 203PbVMT01 followed a few weeks later by PETCT scans utilizing 68GaVMT02 or vice versa The order of the imaging agents will be randomly assigned
The study will be a cross-over study with the participants serving as their own comparator Participants with positive FDG-PET scans for stage IV or inoperable stage III metastatic melanoma will undergo SPECTCT scans utilizing 203PbVMT01 followed a few weeks later by PETCT scans utilizing 68GaVMT02 or vice versa The order of the imaging agents will be randomly assigned
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None