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Diagnostic Performance - ClinicalTrials.gov

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Last Updated: 04 August 2022

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Diagnostic Performance of Fluorescein as an Intraoperative Brain Tumor Biomarker: Correlation With Preoperative MR, ALA-induced PpIX Fluorescence, and Histopathology

Both fluorescein and ALA or fluorescein alone will be randomized on a 2 to 1 basis, and LGG patients will be chosen on a 1 to 1 basis. This is a qualitative review of fluorescein fluorescence as an intraoperative imaging biomarker during open cranial surgery for tumor resection of first-time suspected high or low grade glioma. Patients receiving ALA who have abnormally elevated LFTs beyond the peri-operative observation period are monitored on a regular basis until completion, and this blood testing is considered part of the study. Patients in the fluorescein+ALA arm will be given orally 5-ALA at 20 mg/kg body weight, dissolved in 100 ml of water, approximately three hours before the induction of anesthesia.

Source link: https://clinicaltrials.gov/ct2/show/NCT02691923


Phase III Study for Evaluation of the Diagnostic Performance of [18F]CTT1057 PET Imaging in Patients With Prostate Cancer With Rising PSA Levels [Biochemical Recurrence (BCR)]

This is a prospective, open-label, single-arm Phase III study that seeks the diagnostic success of [18F]CT1057 as a PET imaging agent for detection and localization of PSMA positive tumors in PCa patients diagnosed with biochemical recurrence after initial definitive therapy with either radical prostatectomy or curative intent radiation therapy, using a CTS as reference. Both participants will undergo two PET/CT scans: one with the investigational agent [18F]CT1057 and another with [68Ga]Ga-PSMA-11] as a part of the CTS Level 2 scheme and the other with the secondary endpoint of testing concordance between the two PET/CT scans for detection of lesions.

Source link: https://clinicaltrials.gov/ct2/show/NCT04838613


Phase II/III Study for Evaluation of the Diagnostic Performance of [18F]CTT1057 PET Imaging for the Detection of PSMA Positive Tumors Using Histopathology as a Standard of Truth

Tissue samples from both the primary tumor and pelvic lymph nodes dissected during surgery from patients with newly diagnosed high risk PCa will be used for the histopathology tests. All participants will receive [18F]CTT1057 for PET/CT scan imaging, and surgery will be performed up to 6 weeks after completion of the [18F]CTT1057 PET/CT scan for pathology analysis of the tissue specimens, but not before 48 hours. The central reading findings of the [18F]CTT1057 PET scan's clinical sensitivity and region-level specificity of the dissected tissue specimens will be compared to the histopathology findings, i. e.

Source link: https://clinicaltrials.gov/ct2/show/NCT04838626

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions