Early access
Sign in
Taking peopleNo phase

^68Ga-grazytracer PET for In Vivo Visualization of Immune Cell Effector Functions

Key facts

Who runs it
Peking University Third Hospital
Where
China1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
80 people, planned
Started
1 Jun 2026
Expected to end
Dec 2028
Type of study
Interventional
Treatments tested
  • ^68Ga-grazytracer PET/CT
Record updated
13 November 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 13 criteriaShow less

Other criteria

  • **Inclusion Criteria:**
  • Age ≥18 years, regardless of sex
  • Ability to understand the study objectives and provide written informed consent
  • Cancer cohort:
  • Patients with a confirmed diagnosis of malignancy who are scheduled to receive systemic anticancer treatment
  • Patients who have not previously received immunotherapy
  • Autoimmune disease cohort:
  • Patients with a confirmed diagnosis of an autoimmune disease, such as systemic sclerosis or systemic lupus erythematosus, with evidence of immune-mediated inflammation
  • Patients who are scheduled to receive or are currently receiving immunomodulatory therapy; **Exclusion Criteria:**
  • Pregnant or breastfeeding women
  • Patients with severe cardiac, hepatic, renal, or other major organ dysfunction who are considered unsuitable for study participation by the investigator
  • Patients unable to tolerate PET/CT imaging or complete the required follow-up assessments
  • Patients with any other condition that, in the investigator's judgment, makes them unsuitable for participation in the study

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

This is a prospective, single-center, exploratory clinical study designed to evaluate the feasibility, safety, and clinical utility of \^68Ga-grazytracer positron emission tomography (PET) for noninvasive in vivo visualization of immune cell effector function in patients with cancer and autoimmune diseases. \^68Ga-grazytracer is a granzyme B (GZMB)-targeted PET radiotracer developed to visualize cytotoxic immune activation.

Read full original descriptionShow less

Approximately 60-80 adult participants will be enrolled in two study cohorts: (1) patients with malignant tumors who are scheduled to receive systemic anticancer therapy, including immune checkpoint inhibitors, CAR-T cell therapy, chemotherapy, radiotherapy, targeted therapy, or combination therapy; and (2) patients with autoimmune diseases, including systemic lupus erythematosus, systemic sclerosis, and immune myocarditis, who are receiving or planning to receive immunomodulatory treatment.

Participants will undergo \^68Ga-grazytracer PET/CT imaging before treatment initiation and again during the predefined treatment period. Imaging findings, including tracer uptake and semiquantitative parameters (e.g., SUVmax and target-to-background ratio), will be analyzed together with clinical outcomes, laboratory findings, disease activity assessments, and follow-up data.

The primary objectives are to evaluate the safety and tolerability of \^68Ga-grazytracer PET imaging and to investigate the association between GZMB-targeted PET imaging and treatment response in patients with cancer, disease activity and organ involvement in autoimmune diseases, and therapeutic response to immunomodulatory treatment. This study aims to provide preliminary evidence supporting the use of \^68Ga-grazytracer PET as a molecular imaging biomarker for noninvasive assessment of immune effector function in cancer and autoimmune diseases.

The group in the trial

  • ^68Ga-grazytracer PET ImagingTreatment being tested

    All enrolled participants will undergo \^68Ga-grazytracer PET/CT imaging according to the study protocol for noninvasive assessment of immune cell effector function. Participants include patients with cancer and autoimmune diseases. PET/CT imaging will be performed before treatment initiation and during the predefined treatment period according to the study protocol. Imaging findings will be correlated with clinical characteristics, treatment response, and disease activity.

    Treatment: ^68Ga-grazytracer PET/CT

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
In Vivo Visualization of Immune Cell Effector Functions Using ^68Ga-grazytracer PET: An Exploratory Study of Cancer and Autoimmune Diseases
Record updated
13 November 2026