PD-L1 Specific [68Ga]-Nb-1 Nanobody Probe for PET Imaging in Solid Tumors

Solid Tumor Clinical Trial

Official title:

PD-L1 Specific [68Ga]-Nb-1 Nanobody Probe for PET Imaging in Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06383598
• Other study ID #: 2022KT74-ZY01
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2024
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: Peking University Cancer Hospital & Institute
• Contact: Hua Zhu
• Phone: 010-88196495
• Email: zhuhuabch[@]pku.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Aged >18 years old; ECOG 0 or 1;

2. Patients with solid tumors;

3. Has at least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST V1.1);

4. life expectancy >=12 weeks.

Exclusion Criteria:

1. Significant hepatic or renal dysfunction;

2. Is pregnant or ready to pregnant;

3. Cannot keep their states for half an hour;

4. Refusal to join the clinical study;

5. Suffering from claustrophobia or other mental diseases;

6. Any other situation that researchers think it is not suitable to participate in the experiment

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• 18F-FDG
All study participants will undergo one 18F-FDG PET/CT scan.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Cancer Hospital & Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standardized uptake value(SUV)	The uptake of the tracer (68Ga-Nb-1) in solid tumor lesions or suspected tumor lesions by measuring SUV on PET/CT.	2 years