PD-L2 Targeting Nanobody Radiotracer for PET Imaging of Solid Tumor

NCT05803746 | Unknown

• 1 other identifier: 2022KT114
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to construct a noninvasive approach using 68Ga- Mirc415 PET/CT to detect the PD-L2 expression of tumor lesion in patients with colorectal cancer, lung cancer and other solid tumor to identify patients benefiting from anti-PD-(L)1 treatment.

Conditions

Lung Cancer; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• MPR

  In the surgical pathology after neo-adjuvant immunotherapy, the proportion of active tumors was less than 10%.

  [Time Frame: After 2-4 cycles of immunotherapy (each cycle is 28 days)]

Secondary Outcomes (1)

• PFS

  2 years

Study Arms (1)

Imaging cohort

EXPERIMENTAL

All enrolled participants will be allocated to this arm (single-arm study). Study participants will undergo 68Ga-Mirc415 PET/CT scan.

Drug: 18F-FDG

Interventions

18F-FDG DRUG

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

Imaging cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-75, male and female, with ECOG score of 0 or 1;
• Subjects with head and neck tumors, lung cancer, esophageal cancer, breast cancer, ovarian cancer, cholangiocarcinoma, colorectal cancer, gastric cancer, pancreatic cancer, melanoma, bone or soft tissue sarcoma, solid tumors or suspected tumor subjects who intend to undergo pathological tissue biopsy or receive tumor surgical treatment in the near future (within 2 months);
• The expected survival was more than 26 weeks;
• Blood routine test, liver and kidney function meet the following standards: blood routine: WBC \>= 4.0 x 10\^9/L or neutrophil \>= 1.5 x 10\^9/:, PLT \>= 100 x 10\^9 / L, Hb \>= 90g / L; Pt or APTT \<= 1.5 upper limit of normal value; liver and kidney function: total bilirubin \<= 1.5 x ULT (upper limit of normal value), ALT / AST \<= 2.5 upper limit of normal value or \<= 5 x ULT (subject with liver metastasis), ALP \<= 2.5 upper limit of normal value (if bone metastasis or liver metastasis exists, ALP \<= 4.5 upper limit of normal value); BUN \<= 1.5 x ULT, SCR \<= 1.5 x ULT;
• According to RECIST1.1, there was at least one measurable target lesion;
• Women must take effective contraceptive measures during the study period and within 6 months after the end of the study; men should agree to use contraceptive measures during the study period and within 6 months after the end of the study period;
• Understand and sign informed consent voluntarily with good compliance.

You may not qualify if:

• The function of liver and kidney was seriously abnormal;
• Preparation for pregnant, pregnant and lactating women;
• Inability to lie flat for half an hour;
• Suffering from claustrophobia or other mental disorders; 5) Other researchers considered it unsuitable to participate in the trial. -

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Colorectal Neoplasms

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Central Study Contacts

Zhi Yang

CONTACT

010-88196196; pekyz@163.com

Hua Zhu

CONTACT

010-88196495; zhuhuabch@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 7, 2023
• Study Start: July 15, 2022
• Primary Completion: July 15, 2024
• Study Completion: July 15, 2024
• Last Updated: April 7, 2023

Record last verified: 2023-03

Locations

CN (1)