A Phase 2 interventional study of 68Ga-NY104 PET/CT in Clear Cell Renal Cell Carcinoma, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-13.
Sponsored by Peking Union Medical College Hospital · Phase 2, Interventional, and Diagnostic
This is a prospective, single-center, single-arm phase 2 study in patients with clear cell renal cell carcinoma and metastasis or recurrence suspicion. The goal is to determine the sensitivity and specificity of 68Ga-NY104 PET/CT in patients with clear cell renal cell carcinoma and metastasis or recurrence suspicion
This is a prospective, single-center, single-arm phase 2 study in patients with clear cell renal cell carcinoma and metastasis or recurrence suspicion. Each patient will receive one dose of 68Ga-NY104. Dedicated whole-body PET/CT imaging will be performed. PET/CT studies will be interpreted by two readers, both of whom will provide independent and blinded interpretations. Imaging interpretations and a composite ground truth will be used to estimate the diagnostic efficacy of 68Ga-NY104 PET/CT.
A total of 40 patients will be recruited at Peking Union Medical College Hospital.
1,992 studies on the registry are indexed under Carcinoma, Renal Cell; 387 are open to participants now.
This study's planned enrollment of 40 is close to the median of 42 across 1,501 interventional studies indexed under Carcinoma, Renal Cell.
Browse Carcinoma, Renal Cell studies →Peking Union Medical College Hospital is the lead sponsor of 1,148 studies on the registry; 473 are open to participants now.
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Exclusion Criteria:
Each patient will receive one dose of 68Ga-NY104 by intravenous route. Dedicated whole-body PET/CT imaging will be performed.
Diagnostic Test: 68Ga-NY104 PET/CT
Participants will be administered a single, intravenous bolus of 68Ga-NY104 The recommended administered activity of 68Ga-NY104 is 1.8-2.2 MBq per kilogram bodyweight, subject to variation that may be required owing to variable elution efficiencies obtained during the lifetime of the 68Ga / 68Ga generator The CT and PET imaging session will begin approximately 45 to 75 minutes after 68Ga-NY104 administration.
Also known as: 68Ga-NYM005 PET/CT
Binary reading of lesions identified on 68Ga-NY104 PET/CT
Any focal accumulation in the lesion suspected of metastasis or recurrence that cannot be explained by physiologic uptake of 68Ga-NY104 will be interpreted as PET positive.
Time frame: From study completion to 1 month after completion
Plan to share: Yes — Available upon request
Supporting information: Study protocol
Time frame: Within 2 years after the publication of the main results
Access criteria: No limit.
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Peking Union Medical College Hospital →