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Clinical Trials in China / NCT06922903
Starting soon Phase 3

Phase III Clinical Trial to Evaluate INR101 Injection for PET/CT Imaging in Patients With Prostate Cancer.

NCT06922903 · tracked via the Priya Life Science China tracker
Sponsor
Yunhe Pharmaceutical (Tianjin) Co., Ltd
Phase
Phase 3
Started
2025-04
Last updated
2025-04-13

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

INR101

INR101: INR101

Study summary

A multicenter, open-label, prospective Phase III clinical trial to evaluate INR101 injection for PET/CT imaging in patients with Prostate Cancer

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Males aged ≥18 years old 2. ECOG score of 0 or 1 3. Participants confirmed as prostate adenocarcinoma by histological pathological diagnosis before surgery, and meets the diagnostic criteria for intermediate-risk and above localized prostate cancer in the 2023 CSCO (Chinese Society of Clinical Oncology) guidelines (clinical T stage ≥ T2b; or PSA \> 10 ng/mL; or Gleason \> 6 score) 4. Intended to undergo radical prostatectomy accompanied by pelvic lymph node dissection 5. Routine blood tests, liver and kidney function, and coagulation function meet the corresponding conditions: * Platelet count \> 100×10⁹/L. * Blood urea nitrogen/urea and serum creatinine ≤ 1.5 x ULN. * AST, ALT, and ALP ≤ 2.5 x ULN. * Total bilirubin≤ 1.5 x ULN. * PT and APTT≤ 1.5 x ULN. 6. Life expectancy of at least 6 months as assessed by investigator 7. Agree to use contraceptive measures from the date of signing the informed consent form to 3 months after medication administration, and avoid sperm donation 8. The participant/legal authorized representative understands the purpose and procedures of the trial and signs the informed consent form Exclusion Criteria: 1. Participants who are unable to complete the imaging as required 2. Having had ≥ 2 types of malignant tumors within 5 years prior to the first administration, with the exception of fully treated non-metastatic thyroid cancer, basal cell carcinoma of the skin, superficial squamous cell carcinoma of the skin, and superficial bladder cancer. 3. Participants who have previously received, are currently receiving, or plan to receive (from the signing of the informed consent form until the acquisition of the pathological sample) androgen deprivation therapy or any anti-tumor therapy such as radiotherapy, chemotherapy, or endocrine therapy during the trial period. 4. Participants in other interventional clinical trials and within 5 half-lives of the investigational medicinal product or participants in other interventional clinical trials before signing the informed consent form; or participants in clinical trials of radioactive therapeutic drugs before signing the informed consent form and the time from the drug withdrawal to the signing date of the informed consent form is less than 3 months. 5. Have received intravenous iodine contrast agent within 24 hours prior to the administration of INR101, or have received any high-density oral contrast agent within 5 days (except for those who, as judged by the investigator, have no residual contrast agent in the intestines; oral water-soluble contrast agents are acceptable). 6. Participants with a history of salivary gland diseases or Paget's disease 7. Participants with hip joint prostheses 8. Known allergy to the active ingredients of INR101 or its components 9. Serum virology examination, including positive treponema pallidum antibody, positive HIV antibody, positive hepatitis C antibody with positive hepatitis C virus ribonucleic acid (HCV RNA), or active hepatitis B (for those with positive hepatitis B surface antigen, hepatitis B virus deoxyribonucleic acid (HBV DNA) needs to be detected, and if the HBV DNA is positive). (Note: If the investigator assesses and determines that active hepatitis B is not a contraindication for surgery, the participant may be enrolled in the study.) 10. Investigators judge that there are any medical diseases or other conditions that may affect safety, compliance or may affect the study results.

Primary outcome measure(s)

Trial sites (32)

FacilityCityRegionStatus
Beijing Chao-Yang Hospital, Capital Medical University Beijing Beijing Municipality
Cancer Hospital, Chinese Academy of Medical Sciences Beijing Beijing Municipality
Peking University First Hospital Beijing Beijing Municipality
Beijing Friendship Hospital, Capital Medical University Beijing Beijing Municipality
Peking University Shougang Hospital Beijing Beijing Municipality
Peking University Third Hospital Beijing Beijing Municipality
Beijing Hospital Beijing Beijing Municipality
Beijing GoBroad Hospital Beijing Beijing Municipality
Cangzhou Central Hospital Cangzhou Hebei
Wuhan Central Hospital Wuhan Hubei
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei
Tongji Hospital, Tongji Medical College of HUST Wuhan Hubei
Zhongnan Hospital of Wuhan University Wuhan Hubei
Yichang Central People's Hospital Yichang Hubei
Xiangya Hospital of Central South University Changsha Hunan
Hunan Cancer Hospital Changsha Hunan
The Third Xiangya Hospital of Central South University Changsha Hunan
Nanjing First Hospital Nanjing Jiangsu
Jiangsu Province Hospital Nanjing Jiangsu
The Second Affiliated Hospital of Soochow University Suzhou Jiangsu
The First Affiliated Hospital of Soochow University Suzhou Jiangsu
Taizhou People's Hospital Taizhou Jiangsu
Zhongshan Hospital, Fudan University Shanghai Shanghai Municipality
Shanghai General Hospital Shanghai Shanghai Municipality
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai Shanghai Municipality
Shanghai Sixth People's Hospital Shanghai Shanghai Municipality
Shanghai Changhai Hospital Shanghai Shanghai Municipality
Tianjin First Central Hospital Tianjin Tianjin Municipality
The Second Hospital of Tianjin Medical University Tianjin Tianjin Municipality
Tianjin Cancer Hospital Airport Hospital Tianjin Tianjin Municipality
Zhejiang Provincial People's Hospital Hangzhou Zhejiang
Zhejiang Cancer Hospital Hangzhou Zhejiang

More Yunhe Pharmaceutical (Tianjin) Co., Ltd trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06922903 on ClinicalTrials.gov ↗ ← All trials in China