Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [18F]CTT1057
CTT1057 · 2 trials · 3 indications
Region-level correct localization rate (CLR) is defined as the percentage of regions containing at least one True Positive (TP) lesion (exactly localized correspondence between PET imaging and the reference standard), regardless of any co-existent False Positive (FP) findings within the same region, out of all regions containing at least one PET-positive finding.
Patient-level positive predictive value (PPV) is defined as the percentage of participants who have at least one True Positive (TP) lesion (exactly localized correspondence between PET imaging and the reference standard), regardless of any co-existent False Positive (FP) findings, out of all participants who are PET/CT scan positive.
Sensitivity of vidoflufolastat (18F) Positron Emission Tomography (PET) imaging, considering Prostate Specific Membrane Antigen (PSMA) positive patients as those who show at least one pathological vidoflufolastat (18F) uptake either in the primary tumor and/or metastatic Pelvic Lymph Node (PLN) regions, with anatomically localized correspondence with the Standard of Truth (SoT).
Specificity of vidoflufolastat (18F) PET imaging, defined as proportion of PLN regions that test negative for lymph nodes on vidoflufolastat (18F) among those that are lymph node negative on the SoT.
| Arm | Type | Description |
|---|---|---|
| PET/CT imaging with [18F]CTT1057 followed by [68Ga]Ga-PSMA-11 or vice versa | EXPERIMENTAL | All eligible participants were assigned to one of the following two PET/CT scan sequences at random in a 1:1 ratio: * Sequence 1: \[18F\]CTT1057 on Day 1 (investigational imaging agent of interest) followed by \[68Ga\]Ga-PSMA-11 at least 14 days apart (as part of CTS if required, and for secondary endpoint) * Sequence 2: \[68Ga\]Ga-PSMA-11 (as part of CTS if required, and for secondary endpoint) on Day 1 followed by \[18F\]CTT1057 (investigational imaging agent of interest) at least 14 days apart |
| PET/CT imaging with [18F]CTT1057 | EXPERIMENTAL | All eligible participants will be enrolled to receive \[18F\]CTT1057 imaging agent on Day 1 and have PET/CT scan |
| Name | Type | Description |
|---|---|---|
| [18F]CTT1057 | DRUG | Single intravenous dose of approximately 370 Mega-Becquerel (MBq) and subsequent PET/CT scan |
| [68Ga]Ga-PSMA-11 | DRUG | Single intravenous dose of approximately 150 MBq and subsequent PET/CT scan |
Inclusion Criteria * Signed informed consent must be obtained prior to participation in the study * Biopsy proven prostate adenocarcinoma. * Biochemical recurrence following initial definitive therapy (with either RP or curative intent radiation therapy) as defined: by AUA criteria (Cookson et al ...
CTT1057 is an imaging agent being developed for use in prostate cancer, also called prostatic neoplasms. It is studied as a diagnostic tool for detecting PSMA-positive tumors and for evaluating biochemical recurrence of prostate cancer. It is not a therapeutic treatment; it is intended to help visualize prostate cancer lesions during diagnostic imaging.
CTT1057 is being developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the clinical trials evaluating this imaging agent in prostate cancer.
CTT1057 has been evaluated in Phase 2 and Phase 3 clinical trials. Two trials have been completed, and there are currently no active trials listed for this agent. It is an investigational imaging agent and has not been approved by the FDA.
CTT1057 has been studied in two completed clinical trials: NCT04838626, a Phase 2 study of diagnostic performance for PSMA-positive tumor detection, and NCT04838613, a Phase 3 study of diagnostic performance in biochemical recurrence. Both trials enrolled adult male participants with prostate cancer across sites in the United States and Europe.
Yes, CTT1057 is also known as [18F]CTT1057. The bracketed notation indicates the radiolabeled form of the compound used in positron emission tomography (PET) imaging. Both names refer to the same imaging agent being developed by Novartis.