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NCT06756217Recruiting

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

Source: ClinicalTrials.gov · Last updated 1 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
40 (estimated)
First submitted
25 Dec 2024
Start date
30 Dec 2024
Primary completion date
30 Jun 2026
Lead sponsor
Ruijin Hospital
Diseases
Lung cancer
NCT number
NCT06756217

What you commit to

  • Study type: Observational
  • Planned participants: 40
  • From 30 Dec 2024 to the primary completion date, 30 Jun 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Lung cancer that can not be resected or has distant metastasis, or for other reasons can not tolerate surgery;
  • 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;
  • 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;
  • 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;
  • 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.

Lab values

  • Uncontrolled diabetes or fasting blood glucose ≥11.0 mmol/L on the day of the test;

Other

  • Histologically confirmed were NOT NSCLC;
  • Women who are or may become pregnant, and lactating women are excluded;

Who the study is looking for

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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.