Actively Recruiting
Therapeutic Efficiency and Response to 177Lu-AB-3PRGD2 in Patients With Integrin αVβ3 Positive Tumors
Led by Peking Union Medical College Hospital · Updated on 2024-06-13
10
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and therapeutic response of a new drug called 177Lu-AB-3PRGD2 in patients with tumors that test positive for Integrin αVβ3. This drug is designed to target these specific tumors, which express this integrin highly, making it a promising option for diagnosis and treatment. The study is an early phase 1, open-label, non-controlled, and non-randomized trial focused on measuring the radiation absorbed dose and therapeutic effects in patients whose tumors show high uptake of the drug. Participants receive a single intravenous dose of 1.48 GBq (40 mCi) of 177Lu-AB-3PRGD2 within one week after a whole-body 68Ga-RGD PET/CT scan to confirm tumor suitability. After treatment, blood samples are collected at multiple time points to measure drug radioactivity. Patients undergo serial whole-body planar and SPECT/CT imaging at several intervals to monitor the radiation distribution and assess the treatment response. During the study, participants will be closely monitored with repeated imaging and blood tests at scheduled times up to 168 hours post-injection. Researchers will analyze the internal radiation dose absorbed by normal organs and tumors and collect data on any adverse events for up to two months. The primary outcome is the standardized uptake value of the drug in both tumors and normal tissues over a one-year period. The study involves adults aged 18 to 80 years with integrin-positive tumors that have not responded to standard treatments.
CONDITIONS
Brief Title
177Lu-AB-3PRGD2 in Patients With Integrin αVβ3 Positive Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a clear pathological diagnosis and ineffective or progressing conventional treatment
- Tumor lesions with high uptake confirmed by 68Ga-RGD PET/CT within one week before treatment
- Signed written informed consent
You will not qualify if you...
- Serum creatinine level above 150 µmol/L
- Hemoglobin level less than 10.0 g/dl
- White-cell count less than 4.0 × 10⁹/L
- Platelet count less than 100 × 10⁹/L
- Total bilirubin level more than three times the upper normal limit
- Serum albumin level more than 3.0 g/dl
- Cardiac insufficiency including carcinoid heart valve disease
- Severe allergy or hypersensitivity to radiographic contrast material
- Claustrophobia
- Any medical condition that may significantly interfere with study compliance as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for 68Ga-RGD PET/CT scan and eligibility assessment
Duration - Within 1 week
Participants receive a single intravenous injection of 1.48 GBq of 177Lu-AB-3PRGD2 and undergo serial imaging and blood sampling to evaluate therapeutic response and radiation dosimetry.
1 treatment visit with multiple imaging sessions and 5 blood samples collected at 5 min, 3 h, 24 h, 72 h, and 168 h after administration
Duration - Up to 1 year
Participants are monitored for adverse events and treatment response over 2 months, with long-term evaluation of standardized uptake values up to 1 year.
Periodic assessments for adverse events and imaging as per study schedule
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
Z
Zhaohui Zhu, MD
G
Guochang Wang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Frequently Asked Questions
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