68Ga-grazytracer PET Assists in Diagnosing Pseudoprogression Following Immunotherapy in Lung Cancer.

NCT06608160 | Recruiting DMC

• 1 other identifier: 2024-350
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Currently, there are limited methods available in clinical practice to distinguish pseudoprogression after immunotherapy. Most patients rely on follow-up observations to monitor the disease, which does not meet clinical needs. 68Ga-grazytracer is a novel imaging agent targeting granzyme B. By detecting the concentration of granzyme B, it reflects the localization of cytotoxic T cells in the tumor region and their potential ability to kill tumor cells. This study aims to leverage the simplicity, non-invasiveness, visualization, and semi-quantitative advantages of 68Ga-grazytracer PET imaging to evaluate its effectiveness and feasibility in diagnosing pseudoprogression.

Conditions

PET / CT; Lung Carcinoma; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance 1

  Sensitivity and specificity of 68Ga-grazytracer PET in diagnosing pseudoprogression

  Follow-up for 4-8 weeks, not exceeding 12 weeks.

Secondary Outcomes (1)

• Diagnostic performance 2

  Follow-up for 4-8 weeks, not exceeding 12 weeks.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients are enrolled from Department of Respiratory and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine in China.

You may qualify if:

• Lung cancer patients who develope lesion enlargement and/or new lesions after treatment with immune checkpoint inhibitors;
• Pseudoprogression cannot be ruled out in clinical practice;
• Lung cancer confirmed by pathology or cytology, regardless of pathological type;
• Fully-informed written consent obtained from patients;
• Patient ability to comply with protocol requirements;
• Age 18-75 years;
• Life expectancy of at least 6 months.

You may not qualify if:

• Patients with serious diseases that the investigator deems unsuitable for participation in the clinical study. Such as severe cardiopulmonary insufficiency, severe bone marrow suppression, severe hepatic or renal insufficiency, etc;
• Intestinal perforation, complete intestinal obstruction;
• Active phase of hepatitis B；
• Pregnant women and women who are potentially pregnant, as well as nursing mothers;
• Patients with poor compliance.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: June 20, 2024
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 23, 2024

Record last verified: 2024-09

Locations

CN (1)