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RecruitingNCT06623487Updated Oct 2, 2024

The Application Value of 68Ga-grazytracer PET in Immunotherapy for Stage III Non-small-cell Lung Cancer

An observational study in Carcinoma, Non-Small-Cell Lung, PET / CT and Neoadjuvant Immunotherapy, sponsored by Ruijin Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-10-02.

Sponsored by Ruijin Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Jul 2024; still recruiting 2 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Neoadjuvant immunotherapy can significantly improve the pathological complete response (pCR) and major pathological response (MPR) rates in resectable stage III non-small cell lung cancer (NSCLC), and extend the event-free survival (EFS). However, the current means for evaluating its efficacy are limited. This study aims to utilize the convenient and non-invasive 68Ga-grazytracer PET imaging to detect the aggregation of CD8+ T cells in target lesions after neoadjuvant immunotherapy for stage III NSCLC, and to assess its value in efficacy monitoring, providing valuable information for clinical treatment decisions.

02

Conditions studied

  • Carcinoma, Non-Small-Cell Lung
  • PET / CT
  • Neoadjuvant Immunotherapy
03

In context

Carcinoma, Non-Small-Cell Lung

6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.

This study's planned enrollment of 30 is below the median of 164 across 974 observational studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Ruijin Hospital is the lead sponsor of 667 studies on the registry; 376 are open to participants now.

Browse Ruijin Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients with stage III NSCLC, after assessment according to clinical guidelines, require neoadjuvant immunotherapy;
  2. Fully-informed written consent obtained from patients;
  3. Patient ability to comply with protocol requirements;
  4. Age 18-75 years;
  5. Life expectancy of at least 6 months.

Exclusion criteria

Exclusion Criteria:

  1. 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;
  2. Intestinal perforation, complete intestinal obstruction;
  3. Patients with uncontrolled diabetes mellitus or a fasting blood glucose value of ≥11 mmol/L on the day of the test;
  4. Pregnant women and women who are potentially pregnant, as well as nursing mothers;
  5. Patients with poor compliance.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Predictive performance 1

    Sensitivity and specificity of 68Ga-grazytracer PET in predicting pathological response.

    Time frame: up to the end of surgery

Secondary outcomes

  1. Predictive performance 2

    Assessing the predictive value of 68Ga-grazytracer PET for adjuvant immunotherapy efficacy after surgery, as measured by disease-free survival

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
    Shanghai, Shanghai Municipality 200000, China
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2024 (actual). Primary completion is estimated for Jun 2026, 23 months after the start.

Of 312 non-industry observational studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 155. This study's planned 23 months is below that.

Counting every sponsor, half of 440 studies reached it within 56 months; a quarter within 36 and three quarters within 89.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 19, 2024
First posted
Oct 2, 2024
StartActual
Jul 19, 2024
Primary completionEst.
Jun 30, 2026
CompletionEst.
Jul 31, 2027
Last update
Oct 2, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06623487
Lead sponsor
Ruijin Hospital
Responsible party
Sponsor
First posted
Oct 2, 2024
Start date
Jul 19, 2024
Primary completion
Jun 30, 2026 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
Oct 2, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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