Multicenter Study of 18F-Labeled NY104 for PET/CT Imaging in Renal Cell Carcinoma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- SUV
Study Overview
Brief Summary
This study aims to evaluate the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 18F-NY104 PET/CT in detecting primary, recurrent, and metastatic lesions of renal cell carcinoma (RCC), and to explore its potential for imaging and treatment response assessment in other CAIX-positive solid tumors, such as breast cancer and nasopharyngeal carcinoma, where high CAIX expression is associated with poor prognosis. The study will also investigate the effect of oral low-dose acetazolamide on the biodistribution of 18F-NY104, particularly in the stomach and kidneys.
Detailed Description
Kidney disease affects more than 500 million people worldwide, including approximately 120 million individuals in China. Among various kidney diseases, renal cell carcinoma (RCC) represents one of the most serious malignant conditions affecting the kidney and is one of the most common malignancies of the urinary system. The incidence of RCC in China has increased in recent years. Early-stage RCC is often asymptomatic and may be detected incidentally during routine health examinations. However, RCC is an aggressive malignancy, and a substantial proportion of patients present with metastatic disease at initial diagnosis or develop recurrence and metastasis after surgery. Therefore, accurate detection of primary, recurrent, and metastatic lesions is important for diagnosis, staging, restaging, treatment planning, and prognosis assessment.
Carbonic anhydrase IX (CAIX) is a transmembrane glycoprotein of the carbonic anhydrase family and is closely associated with the von Hippel-Lindau (VHL)/hypoxia-inducible factor (HIF) signaling pathway. By regulating intracellular and extracellular pH under hypoxic conditions, CAIX contributes to tumor cell survival, proliferation, invasion, and metastasis. CAIX has limited expression in most normal tissues but is highly expressed in RCC, particularly clear cell RCC, making it an attractive molecular target for tumor imaging and therapy. Moreover, CAIX overexpression is observed in a variety of other solid tumors, including breast cancer and nasopharyngeal carcinoma, and has been associated with tumor hypoxia, aggressive tumor characteristics, and poor prognosis. Thus, non-invasive assessment of CAIX expression may provide clinically relevant information for tumor detection, characterization, prognosis assessment, and treatment response evaluation in RCC and other CAIX-positive solid tumors.
18F-NY104 is a novel CAIX-targeted PET imaging agent with favorable radiochemical and imaging characteristics. Preclinical studies have demonstrated its specific binding to CAIX expressed on tumor cells, as well as favorable pharmacokinetics and imaging performance, supporting its potential for non-invasive, whole-body assessment of CAIX-positive tumors.
This study will evaluate the diagnostic performance of 18F-NY104 PET/CT for detecting primary, recurrent, and metastatic RCC lesions and explore its potential application in other CAIX-positive solid tumors, including breast cancer and nasopharyngeal carcinoma. Its potential value for non-invasive assessment of CAIX expression and treatment response will also be investigated. In addition, the study will evaluate the effect of oral low-dose acetazolamide, a CAIX inhibitor, on the biodistribution of 18F-NY104, particularly physiological uptake in the stomach and kidneys, and its potential impact on lesion visualization and image interpretation.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Capable of understanding and voluntarily signing the informed consent form; able to complete the trial in accordance with the protocol requirements;
- •Age 18-75 years; no gender restrictions;
- •Clinically diagnosed/suspected renal cell carcinoma, clinically diagnosed/suspected recurrence and/or metastasis after treatment of renal cell carcinoma, or CAIX-positive solid tumors, including but not limited to breast cancer and nasopharyngeal carcinoma;
- •At least 1 measurable solid lesion in the subject, which can be accurately and continuously measured using modified RECIST criteria (version 1.1);
- •ECOG performance status score of 0-2;
- •Laboratory parameters must meet:
- •Hematology: WBC ≥4.0×10⁹/L or neutrophils ≥1.5×10⁹/L, PLT ≥100×10⁹/L, Hb ≥90 g/L; PT or APTT ≤1.5×ULN (upper limit of normal);
- •Liver and kidney function: T-Bil ≤1.5×ULN, ALT/AST ≤2.5×ULN or ≤5×ULN (for subjects with liver metastasis), ALP ≤2.5×ULN (if bone or liver metastasis is present, ALP ≤4.5×ULN); BUN ≤1.5×ULN, SCr ≤1.5×ULN;
- •Other routine tests: Within normal ranges or deemed acceptable by the investigator;
- •Expected survival ≥12 weeks;
- •Female subjects: Effective contraception (defined as sterilization, intrauterine hormone device, condoms, contraceptives/agents, abstinence, or partner vasectomy) must be used during the study and for 6 months post-study; Male subjects: Agreement to use contraception during the study and for 6 months post-study.
Exclusion Criteria
- •Recovery from major trauma (including surgery) within 4 weeks prior to study examination;
- •Patients with systemic or local severe infections or other serious comorbidities;
- •Severe hepatic or renal dysfunction;
- •Refusal to participate in this clinical study;
- •Patients with a history of allergy to any component of the imaging agent (including antibodies) or allergic constitution;
- •Childbearing-aged male or female subjects who cannot adopt effective contraception;
- •Women planning pregnancy, currently pregnant, or lactating;
- •Patients unable or unwilling to undergo PET/CT scanning;
- •Other subjects deemed ineligible by the investigator.
Arms & Interventions
18F-NY104 PET/CT scan
Intervention: 18F-NY104 PET/CT (Radiation)
Outcomes
Primary Outcomes
SUV
Time Frame: 2 years
The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value (SUV) on PET/CT
Secondary Outcomes
No secondary outcomes reported