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68Ga-PSMA-11 · 2 trials · 11 indications
To evaluate the diagnostic performance of combined 68Ga-PSMA-11 PET and MRI targeted biopsy for the detection of PCa, using histopathological confirmation as the SOT.
To assess the sensitivity and specificity of 68Ga-PSMA-11 PET as adjunct to MRI or the detection of PCa, confirmed by predefined standard of truth (SOT).
The PPV \[PPV (%) = TP\* /(TP + FP\*\*)\] will be determined by the combination of histopathology/biopsy and conventional imaging and/or PSA follow-up results as the true criteria (composite criteria) and the results observed by 68Ga-PSMA-11 PET (positive/negative).
| Arm | Type | Description |
|---|---|---|
| Illuccix: 68Ga-PSMA-11/Gallium Ga 68 Gozetotide | OTHER | This is a single arm study. All participants will first undergo mpMRI and PSMA PET scans (one single IV bolus of Gallium Ga 68 Gozetotide administered) |
| Treatment (68Ga-PSMA-11) | EXPERIMENTAL | 111 \~ 259 MBq 68Ga-PSMA-11 will be administered intravenously to participants over 3- 5 minutes. After 50-100 minutes post 68Ga-PSMA-11 injection, participants will be scanned (PET/CT or PET/MRI) from the mid-thigh to the apex of the skull. Participants will be placed in a supine position with the arms raised overhead. |
| Name | Type | Description |
|---|---|---|
| 68Ga-PSMA-11 | DRUG | The radioconjugate 68Ga-PSMA-11 is composed of a human PSMA-targeting ligand peptide conjugated via the acyclic radiometal chelator, N, N'-bis \[2-hydroxy-5-(carboxyethyl)benzyl\] ethylenediamine-N, N'-diacetic acid (HBED-CC) to the radioisotope Gallium68 ( 68Ga); which binds to PSMA on the surface of cells expressing PSMA, including malignant prostate cancer cells, which usually overexpress PSMA. 68Ga is a β+ (beta) ray emitting radionuclide that allows precise imaging via PET. |
| PET/CT or PET/MRI | OTHER | PET/CT or PET/MRI will be acquired no sooner than 50 minutes post injection and not later than 100 minutes post injection with 68Ga-PSMA-11 |
Inclusion Criteria: 1. Male, at least 18 years old. 2. Have a clinical suspicion of PCa, and will undergo template biopsy, based on either: an initial MRI examination (PI-RADS 3-4) within 3 months (92 days) before enrollment, or no MRI evidence (PI-RADs 1-2) within 3 months (92 days) before enrollm...