PD-L1 Specific [68Ga]-Nb-1 Nanobody Probe for PET Imaging in Solid Tumors
- Registration Number
- NCT06383598
- Lead Sponsor
- Hua Zhu
- Brief Summary
The objective of the study is to constrcut a noninvasive approach 68Ga-Nb-1 PET/CT to detect the PD-L1 expression of tumor lesions in patients with solid tumors and to identify patients benefiting from anti-PD-L1 treatment.
- Detailed Description
Analysis plan: 1. recruit 3 participants to analyze preliminary pharmacokinetic/first-in-human dose (FIH), major organ distribution and tumor uptake information via whole-body PET/CT imaging; 2. recruit 20-30 participants to analyze in vivo safety and tumor targeting information; and 3. recruit all participants for a final summary.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Aged >18 years old; ECOG 0 or 1;
- Patients with solid tumors;
- Has at least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST V1.1);
- life expectancy >=12 weeks.
- Significant hepatic or renal dysfunction;
- Is pregnant or ready to pregnant;
- Cannot keep their states for half an hour;
- Refusal to join the clinical study;
- Suffering from claustrophobia or other mental diseases;
- Any other situation that researchers think it is not suitable to participate in the experiment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 68Ga-Nb-1 18F-FDG All study participants will be allocated to this arm (single-arm study).Study participants will undergo 68Ga-Nb-1 PET/CT scans (At the investigator's discretion, a total of no more than 0.5 mg of non-radiolabeled precursor may be considered for injection. To reduce liver and bone marrow uptake). After resting for 40 minutes or 1 hour, participants underwent United Imaging Healthcare total-body PET/CT for whole body scans or a Siemens Biograph m-CT flow PET/CT from the top of the head to the upper third of the thighs.
- Primary Outcome Measures
Name Time Method Standardized uptake value(SUV) 2 years The uptake of the tracer (68Ga-Nb-1) in solid tumor lesions or suspected tumor lesions by measuring SUV on PET/CT.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China