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

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.

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Key information

Conditions

PET / CT Immunotherapy Lung Carcinoma Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

Location status: Recruiting

Location contact

yi xiang

CONTACT

[email protected]

13816967846

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

Diagnostic performance 1

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

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

Secondary outcomes

Diagnostic performance 2

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

Investigating the optimal uptake value for 68Ga-grazytracer PET/CT imaging in diagnosing pseudoprogression.

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

68Ga-grazytracer PET/CT Assists in Diagnosing Pseudoprogression Following Immunotherapy in Lung Cancer: a Prospective, Observational Study.

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Sep 23, 2024
Registry last updated: Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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