Ignite Creation Date:
2024-07-17 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474806
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-06
Brief Title:
Safety and Diagnostic Performance of uPAR PET Imaging in Localised Untreated Prostate Cancer
Sponsor:
Curasight
Organization:
Curasight
Study Overview
Official Title:
An Open-label Two-part Phase 2 Clinical Trial to Investigate the Safety and Diagnostic Performance of uPAR PET Imaging for Non-invasive Classification of ISUP Grades Among Patients With Localised Untreated Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-06
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:
uTRACE-101
Brief Summary:
The goal of this clinical trial is to test if the experimental agent accurately determines the aggressiveness of prostate cancer biopsy-verified ISUP grade The aim is that the diagnostic PET imaging agent may be used as an alternative or supplement to biopsies in the monitoring of patients with low-risk prostate cancer in active surveillance
Patients diagnosed with untreated low-grade localized prostate cancer may participate in the trial The experimental diagnostic agent 64Cu-DOTA-AE105 is a radiopharmaceutical which is injected into the veins and binds to uPAR expressing cells in the tumour which can then be visualized in a PET scanner
The main question the trial aims to answer is Can the test drug be used alone or as a supplement to repeated biopsies to accurately assess the aggressiveness of prostate cancer
The trial is divided in 2 parts
Participants in the first part will receive 2 injections of test drug on 2 different days
The first day the participant will receive an injection of the test drug and then be asked to lie down in the PETCT scanner so that images of the prostate can be taken Before and after the injectionscanning procedure the participant will have tests done These tests will include evaluation of health status measurement of heart function by ECG plus blood and urine samples
After 8 days the procedures including injection of test drug and scanning will be repeated
Participants in the second part of the trial will only have 1 injection of the test drug and subsequent PETCT scanning Like in Part 1 of the trial tests will be done before and after the injection scanning procedure
Patients diagnosed with untreated low-grade localized prostate cancer may participate in the trial The experimental diagnostic agent 64Cu-DOTA-AE105 is a radiopharmaceutical which is injected into the veins and binds to uPAR expressing cells in the tumour which can then be visualized in a PET scanner
The main question the trial aims to answer is Can the test drug be used alone or as a supplement to repeated biopsies to accurately assess the aggressiveness of prostate cancer
The trial is divided in 2 parts
Participants in the first part will receive 2 injections of test drug on 2 different days
The first day the participant will receive an injection of the test drug and then be asked to lie down in the PETCT scanner so that images of the prostate can be taken Before and after the injectionscanning procedure the participant will have tests done These tests will include evaluation of health status measurement of heart function by ECG plus blood and urine samples
After 8 days the procedures including injection of test drug and scanning will be repeated
Participants in the second part of the trial will only have 1 injection of the test drug and subsequent PETCT scanning Like in Part 1 of the trial tests will be done before and after the injection scanning procedure
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-507111-35-00 | CTIS | None | None |