Status:

RECRUITING

68Ga-grazytracer PET/CT for Early Assessment of Response to Neoadjuvant Immunotherapy in Resectable NSCLC

Lead Sponsor:

Ruijin Hospital

Conditions:

Non-Small Cell Lung Cancer

Eligibility:

All Genders

18-75 years

Brief Summary

The purpose of this study is to explore the effectiveness of 68Ga-grazytracer PET/CT in early evaluation of neoadjuvant immunotherapy response in resectable NSCLC.

Detailed Description

It is challenging to noninvasively early evaluate the immunotherapy response of cancer. The study will evaluate the application value of 68Ga-grazytracer PET/CT in the early evaluation of neoadjuvant ...

Eligibility Criteria

Inclusion Criteria:

  1. Pre-treatment stage as clinical IB-IIIA (AJCC/UICC 8th Edition);
  2. Curative resectability has to be explicitly verified by the experienced surgical investigator;
  3. Histologically confirmed diagnosis of primary non-small lung cancer.
  4. Men and women aged 18 Years to 75 Years;
  5. Eastern Cooperative Oncology Group (ECOG) performance status: 0-1;
  6. expected survival ≥ 6 months;
  7. Sign on the informed consent form (ICF).

Exclusion Criteria:

  1. Histologically confirmed were NOT NSCLC;
  2. Lung cancer that can not be resected or has distant metastasis, or for other reasons can not tolerate surgery;
  3. Patients with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colorectal, endometrial, cervical, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period;
  4. Any active or history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications. The subjects were innate or acquired immunodeficiency (such as HIV), or active hepatitis (hepatitis B reference: HBsAg) positive; Hepatitis C reference: HCV antibody positive;
  5. Uncontrolled diabetes or fasting blood glucose ≥11.0 mmol/L on the day of the test;
  6. Women who are or may become pregnant, and lactating women are excluded;
  7. Having a history of severe cardiovascular disease, severe myelosuppression and severe hepatic and renal insufficiency. Having a known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
  8. Any medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information.

Key Trial Info

Start Date :

December 30 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 30 2027

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT06756217

Start Date

December 30 2024

End Date

December 30 2027

Last Update

January 1 2025

Active Locations (1)

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1

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China, 200025