UnknownPhase 2

68Ga-NY104 PET/CT for the Detection of Clear Cell Renal Cell Carcinoma in Presurgical Patients With Renal Masses

China63 participantsStarted 2023-08-01

Plain-language summary

This is a prospective, single-center, single-arm, diagnostic phase 2 study in patients who have renal masses scheduled for surgical resection. The goal is to determine the sensitivity and specificity of 68Ga-NY104 PET/CT in the detection of clear cell renal cell carcinoma using histopathological diagnosis as ground truth, in patients with operable renal masses.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age ≥ 18 y
✓. Presence of a renal mass
✓. Scheduled for surgical resection of renal mass (partial or total nephrectomy, open, laparoscopic, or robot-assisted technique)
✓. Expected survival of at least 3 months
✓. ECOG ≤ 2
✓. Written informed consent provided for participation in the trial
✓. In the opinion of investigator, willing and able to comply with required study procedures.

Exclusion criteria

✕. On VEGF TKI treatment less than 1 week before 68Ga-NY104 PET/CT. TKI is known to affect girentuximab binding in patients with ccRCC and is expected to have the same effect on 68Ga-NY104. If patients were on VEGF TKI treatment, such as sunitinib, sorafenib, cabozantinib, pazopanib, or lenvatinib, a washout of one week before 68Ga-NY104 PET/CT is required.
✕. Intercurrent medical condition that renders the patient ineligible for surgery.
✕. Pregnancy or breastfeeding.
✕. Severe claustrophobia.

What they're measuring

Binary reading of renal lesions identified on 68Ga-NY104 PET/CT

Timeframe: From study completion to 1 month after completion

Histological classification of operated renal lesions

Timeframe: From study completion to 1 month after completion

Trial details

NCT IDNCT05879510

SponsorPeking Union Medical College Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-01

Contact for this trial

Li Huo, MD

18612672038 huoli@pumch.cn

View on ClinicalTrials.gov More Clear Cell Renal Cell Carcinoma trials