By InvitationPhase 2

68Ga-NYM096 PET/ CT for the Detection of Clear Cell Renal Cell Carcinoma in Presurgical Patients With Renal Masses

China100 participantsStarted 2025-07-01

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-NYM096 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 years;
✓. Gender: No restriction;
✓. Renal mass (solitary or multiple) with a maximum diameter ≥1 cm, confirmed by conventional imaging (ultrasound, non-contrast CT, contrast-enhanced CT, or MRI);
✓. Scheduled for renal mass resection (partial or total nephrectomy, via open, laparoscopic, or robot-assisted techniques) within 1 month;
✓. Life Expectancy:
✓. Informed Consent: Provision of written informed consent;
✓. Compliance: Willing and able to adhere to study procedures.

Exclusion criteria

✕. Surgical Contraindications:
✕. Pregnancy/Lactation:
✕. Other Contraindications:
✕. Any condition deemed by the investigator to interfere with study results or increase participant risk.

What they're measuring

Histological classification of operated renal lesions

Timeframe: From study completion to 1 month after completion

Binary reading of renal lesions identified on 68Ga-NYM096 PET/CT

Timeframe: From study completion to 1 month after completion

Trial details

NCT IDNCT07101900

SponsorPeking Union Medical College Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-01

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