Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as 3'-Deoxy-3'-[18F]-fluorothymidine
3'-Deoxy-3'-fluorothymidine · 1 trial · 1 indication
The mean Dice similarity coefficient (DSC) between active bone marrow volumes derived from CSE-MRI and ¹⁸F-FLT PET across all enrolled patients. A mean DSC of ≥0.7 will indicate that CSE-MRI is a clinically acceptable alternative to FLT PET for identifying ABM
| Arm | Type | Description |
|---|---|---|
| Participants scheduled to receive 177Lu-PSMA | EXPERIMENTAL | Males aged 18 years and older with metastatic PSMA-positive castration-resistant prostate cancer (CRPC) who are scheduled to receive 177Lu-PSMA (PLUVICTO®). Within 7 days prior to 177Lu-PSMA RPT, participants will receive an injection of FLT and then undergo a FLT PET to assess proliferating bone marrow and CSE-MRI to generate a fat fraction map on a GE SIGNA PET/MR scanner. Whole-body single photon emission computed tomography (SPECT/CT) imaging (2-3 bed positions) will be performed per standard of care on Day 0 (3 +/- 2 h), Day 1 (24 +/- 4 h), and Day 4 (96 +/- 24 h) post-177Lu-PSMA RPT infusion. As standard of care, participants will receive up to 6 infusions of 177Lu-PSMA RPT every 6 weeks at UW Health. |
| Name | Type | Description |
|---|---|---|
| 3'-Deoxy-3'-[18F]-fluorothymidine | DRUG | Within 29 days prior to 177Lu-PSMA RPT, participants will undergo 18F-FLT PET to assess proliferating bone marrow and CSE-MRI to generate a fat fraction map on a GE SIGNA PET/MR scanner. This is expected to last 2-3 hours. FLT injections will be administered one hour before imaging for tracer uptake. Participants will receive an IV injection of up to 10 mCi (370 MBq) of 18F-FLT. The patient will receive 1 CSE-MRI/FLT PET scan prior to the start of therapy. |
| Chemical-shift-encoded MRI | DEVICE | Within 29 days prior to 177Lu-PSMA RPT, participants will undergo 18F-FLT PET to assess proliferating bone marrow and CSE-MRI to generate a fat fraction map on a GE SIGNA PET/MR scanner. This is expected to last 2-3 hours. The patient will receive 1 CSE-MRI/FLT PET scan prior to the start of therapy. Up to 3 CSE-MRI scans will be completed as part of this study. At the physician's discretion, a single standard of care (SOC) mid-treatment PSMA PET/MRI can be performed any time during cycles 2-4, and a SOC post-treatment can be done within 6 months of final treatment. CSE-MRI will be acquired during these scans. |
Inclusion Criteria: * Ability to understand and the willingness to sign a written informed consent document. * Patients must be informed of the experimental nature of the study and its potential risks, and must sign institutional review board (IRB) approved consent form indicating such understandin...
3'-Deoxy-3'-fluorothymidine is an investigational small molecule being studied for use in metastatic castration-resistant prostate cancer. It is currently in Phase 1 clinical development and is not yet approved by the FDA.
3'-Deoxy-3'-fluorothymidine is a small molecule that is being evaluated as a biomarker for imaging in metastatic castration-resistant prostate cancer. Its use in the clinical trial is for active bone marrow dosimetry in radiopharmaceutical therapy.
3'-Deoxy-3'-fluorothymidine is being developed by GE HealthCare Technologies Inc., which trades under the ticker GEHC on the stock market.
3'-Deoxy-3'-fluorothymidine is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for any use.
3'-Deoxy-3'-fluorothymidine is being studied in a single clinical trial, NCT07609225, titled 'Chemical-Shift-Encoded MRI for Active Bone Marrow Dosimetry in Radiopharmaceutical Therapy.' This early Phase 1 trial is not yet recruiting and has an enrollment of 15 participants.
Yes, 3'-Deoxy-3'-fluorothymidine is also known as 3'-Deoxy-3'-[18F]-fluorothymidine. The two names refer to the same investigational compound being developed by GE HealthCare Technologies Inc.