NCT07101900Enrolling by invitationPhase 2
68Ga-NYM096 PET/ CT for the Detection of Clear Cell Renal Cell Carcinoma in Presurgical Patients With Renal Masses
68Ga-NYM096 PET/CT for the Detection of Clear Cell Renal Cell Carcinoma in Presurgical Patients With Renal Masses
Source: ClinicalTrials.gov · Last updated 8 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 28 Jul 2025
- Start date
- 1 Jul 2025
- Primary completion date
- 1 Jul 2027
- Lead sponsor
- Peking Union Medical College Hospital
- Diseases
- Kidney cancer
- NCT number
- NCT07101900
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 1 Jul 2025 to the primary completion date, 1 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Other Contraindications:
- Claustrophobia;
- Weight \>150 kg ;
- Alcohol allergy.
- Any condition deemed by the investigator to interfere with study results or increase participant risk.
Lab values
- Surgical Contraindications:
- High anesthesia risk (ASA class ≥IV);
- Severe cardiopulmonary dysfunction (NYHA class III-IV or FEV1 \<50%);
- Active bleeding or coagulation disorders (INR \>1.5, platelets \<80×10⁹/L).
Other
- Pregnancy/Lactation:
- Pregnant (positive blood/urine HCG) or breastfeeding women;
- childbearing potential without effective contraception.
Who the study is looking for
- 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:
- At least 3 months, as assessed by a clinician;
- ECOG Performance Status: 0-2;
- Informed Consent: Provision of written informed consent;
- Compliance: Willing and able to adhere to study procedures.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.