Actively Recruiting
Therapeutic Efficiency and Response to 177Lu-TATE-RGD in Patients With SSTR2 and Integrin αVβ3 Positive Tumors
Led by Peking Union Medical College Hospital · Updated on 2024-10-15
10
Participants Needed
1
Research Sites
3 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a new treatment called 177Lu-TATE-RGD for patients with tumors that have high levels of SSTR2 and integrin αVβ3. This early-phase research aims to explore how well this treatment works and its potential for targeted radioisotope therapy, especially since previous studies showed that a similar dual-target tracer could better detect certain tumor metastases compared to single-target tracers. In this trial, all participants will first undergo a whole-body 68Ga-TATE-RGD PET/CT scan within one week. They will then receive a single intravenous injection of 177Lu-TATE-RGD at doses ranging from 1.48 to 3.33 GBq (40-100 mCi) within one week after the scan. Blood samples will be collected at several time points up to 168 hours after injection to measure radioactivity. Multiple imaging sessions will be conducted from 3 to 168 hours post-injection to analyze radiation dose and evaluate treatment response. Participants will be monitored through blood tests and imaging to assess how the drug is processed in the body and how tumors respond. The main measurement is the standardized uptake value of 177Lu-TATE-RGD in normal organs and tumors, tracked over an average of six months. Adverse events will also be collected for two months to monitor safety. This study is expected to continue until early 2025, providing valuable information on the therapy's effects and tolerability.
CONDITIONS
Brief Title
177Lu-TATE-RGD in Patients With SSTR2 and Integrin αVβ3 Positive Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a confirmed pathological diagnosis whose conventional clinical treatment was ineffective or disease is progressing
- Tumor lesions showing high SSTR2 and RGD uptake on 68Ga-TATE-RGD PET/CT within one week before 177Lu-TATE-RGD injection
- Signed written consent to participate in the study
You will not qualify if you...
- Serum creatinine level over 150 bcmol per liter
- Hemoglobin level less than 10.0 g/dl
- White-cell count below 4.0 d7 10^9/L
- Platelet count below 100 d7 10^9/L
- Total bilirubin level more than three times the upper normal limit
- Serum albumin level less than 3.0 g per deciliter
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 1 week
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week
Participants receive a single intravenous injection of 177Lu-TATE-RGD to target their tumors.
1 treatment visit with multiple blood sample collections and imaging visits over 7 days
Trial Site Locations
Total: 1 location
1
Chinese Academy of Medical Science & Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
Z
Zhaohui Zhu, 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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