Solid Tumor MalignanciesNCT07039474
The Application of 18F-G1 PET/CT Targeting Granzyme B in the Pan-cancer Immunotherapy
An observational study of Solid Tumor Malignancies and Hematologic Cancer, run by Peking University First Hospital at 1 site in China.
Trial summary
The purpose of this study is to explore the effectiveness of 18F-G1 PET/CT in patients with solid tumors and hematological malignancies receiving immunotherapy Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Solid Tumor Malignancies, Hematologic Cancer, Lung Cancer
- What is being tested?
- 18F-G1
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 8 Sep 2026to 15 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects diagnosed with a malignant tumor (solid tumor or hematological tumor) by histopathology who are going to receive immunotherapy (monotherapy or combined immunotherapy).
Who may be able to join
- Subjects diagnosed with a malignant tumor by histopathology who are going to receive immunotherapy (monotherapy or combined immunotherapy) recommended by the multidisciplinary team.
- Subjects didn't receive previous immunotherapy.
- There exists at least one measurable target lesion according to the RECIST 1.1.
- ECOG performance status≤2.
- The expected survival time is ≥6 months.
- Effective contraceptive measures will be adopted during the study period and within 6 months after the study.
- Willing and able to fully understand and sign the informed consent form.
Who cannot join
- Women in the preconception period, pregnancy, or lactation period.
- Combined with other malignant tumor.
- Diagnosed with autoimmune disease, or have long history of systemic steroid hormone therapy or immunosuppressive therapy.
- Having a history of severe cardiovascular disease, severe hepatic and renal insufficiency.
- Receiving radiotherapy or interventional therapy during the immunotherapy.
- 18F-G1 PET/CT or 18F-FDG PET/CT is not performed in our department, or the interval between baseline imaging and immunotherapy is more than 30 days.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, 100034
Meng Liu, 86-10-83575252, louisa_liu@bjmu.edu.cn
About this study
The purpose of this study is to explore the effectiveness of 18F-G1 PET/CT in patients with solid tumors and hematological malignancies receiving immunotherapy
Read the detailed description
It is urgent to select patients who will benefit from immunotherapy, so as to help the clinicians adjust the regimens and avoid unnecessary side effect. 18F-G1 is a new radioactive tracer targeting granzyme B, holding great promise in assessing early response to immunotherapy. This study will explore the safety of 18F-G1 PET/CT in patients with solid tumors and hematological tumors receiving immunotherapy, analyze its imaging features, and assess its efficacy in predicting early immunotherapy response and prognosis, so as to aid the clinicians in precise patient stratification and regimen adjustment.
- Conditions
- Solid Tumor Malignancies, Hematologic Cancer, Lung Cancer, Esophagus Cancer, Breast Cancer, Kidney Cancer
- Being tested
- 18F-G1
- Medical subject headings
- Hematologic Neoplasms, Lung Neoplasms, Esophageal Neoplasms, Breast Neoplasms, Kidney Neoplasms, Stomach Neoplasms, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-G1Drug
18F-G1 is injected intravenously with a dose of 0.06-0.08mCi/kg
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with 18F-G1-related adverse events (AEs).
The absolute number of participants with AEs after the injection of 18F-G1 according to CTCAE 5.0.
Measured: 3 days after the injection of 18F-G1
Tumor uptake of 18F-G1
The uptake of 18F-G1 in tumors will be quantitatively assessed by SUVmax.
Measured: 40-60 minutes after the injection of 18F-G1
Liver uptake of 18F-G1
The uptake of 18F-G1 in liver will be quantitatively assessed by SUVmax.
Measured: 40-60 minutes after the injection of 18F-G1
Lung uptake of 18F-G1
The uptake of 18F-G1 in lung will be quantitatively assessed by SUVmax.
Measured: 40-60 minutes after the injection of 18F-G1
Kidney uptake of 18F-G1
The uptake of 18F-G1 in kidney will be quantitatively assessed by SUVmax.
Measured: 40-60 minutes after the injection of 18F-G1
the granzyme B specificity of 18F-G1
Measured: 3 years
Assessing the early predictive value of 18F-G1 PET/CT for immunotherapy response.
Participants' overall response will be assessed by RECIST 1.1 criteria or Lugano criteria at the time point of 6 months after immunotherapy. The tumor uptake of 18F-G1 will be compared between the responders and non-responders.
Measured: 6 months
Secondary outcomes (1)
Evaluate the correlation of 18F-G1 accumulation in tumors to long term survival after immunotherapy.
Participants will be categorized into groups with high or low 18F-G1 uptake in tumor lesions. The progression-free survival (PFS) as assessed by RECIST 1.1 criteria or Lugano criteria will be compared between the two groups.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start8 Sep 2026
- Primary completion1 Dec 2028 (estimated)
- Study completion15 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor MalignanciesStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039474
- Sponsor's protocol ID
- 2025R0069
- Status last verified
- Sep 2026
- First submitted
- 26 May 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of 18F-G1 PET/CT Targeting Granzyme B in the Pan-cancer Immunotherapy
- ClinicalTrials.gov ID
- NCT07039474
- Acronym / sponsor ID
- 2025R0069
- Conditions
- Solid Tumor Malignancies, Hematologic Cancer, Lung Cancer, Esophagus Cancer, Breast Cancer, Kidney Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 8 Sep 2026 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 15 Dec 2028 (estimated)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to explore the effectiveness of 18F-G1 PET/CT in patients with solid tumors and hematological malignancies receiving immunotherapy
Detailed description
It is urgent to select patients who will benefit from immunotherapy, so as to help the clinicians adjust the regimens and avoid unnecessary side effect. 18F-G1 is a new radioactive tracer targeting granzyme B, holding great promise in assessing early response to immunotherapy. This study will explore the safety of 18F-G1 PET/CT in patients with solid tumors and hematological tumors receiving immunotherapy, analyze its imaging features, and assess its efficacy in predicting early immunotherapy response and prognosis, so as to aid the clinicians in precise patient stratification and regimen adjustment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects diagnosed with a malignant tumor (solid tumor or hematological tumor) by histopathology who are going to receive immunotherapy (monotherapy or combined immunotherapy).
Key inclusion criteria (7 listed)
- Subjects diagnosed with a malignant tumor by histopathology who are going to receive immunotherapy (monotherapy or combined immunotherapy) recommended by the multidisciplinary team.
- Subjects didn't receive previous immunotherapy.
- There exists at least one measurable target lesion according to the RECIST 1.1.
- ECOG performance status≤2.
- The expected survival time is ≥6 months.
Key exclusion criteria (6 listed)
- Women in the preconception period, pregnancy, or lactation period.
- Combined with other malignant tumor.
- Diagnosed with autoimmune disease, or have long history of systemic steroid hormone therapy or immunosuppressive therapy.
- Having a history of severe cardiovascular disease, severe hepatic and renal insufficiency.
- Receiving radiotherapy or interventional therapy during the immunotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-G118F-G1 is injected intravenously with a dose of 0.06-0.08mCi/kg | Drug | – |
Primary outcome
Number of participants with 18F-G1-related adverse events (AEs).
Time frame: 3 days after the injection of 18F-G1
The absolute number of participants with AEs after the injection of 18F-G1 according to CTCAE 5.0.
Tumor uptake of 18F-G1
Time frame: 40-60 minutes after the injection of 18F-G1
The uptake of 18F-G1 in tumors will be quantitatively assessed by SUVmax.
Liver uptake of 18F-G1
Time frame: 40-60 minutes after the injection of 18F-G1
The uptake of 18F-G1 in liver will be quantitatively assessed by SUVmax.
Lung uptake of 18F-G1
Time frame: 40-60 minutes after the injection of 18F-G1
The uptake of 18F-G1 in lung will be quantitatively assessed by SUVmax.
Kidney uptake of 18F-G1
Time frame: 40-60 minutes after the injection of 18F-G1
The uptake of 18F-G1 in kidney will be quantitatively assessed by SUVmax.
the granzyme B specificity of 18F-G1
Time frame: 3 years
Assessing the early predictive value of 18F-G1 PET/CT for immunotherapy response.
Time frame: 6 months
Participants' overall response will be assessed by RECIST 1.1 criteria or Lugano criteria at the time point of 6 months after immunotherapy. The tumor uptake of 18F-G1 will be compared between the responders and non-responders.
1 secondary outcome
Evaluate the correlation of 18F-G1 accumulation in tumors to long term survival after immunotherapy.
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumor Malignancies and Hematologic Cancer, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caixia Wu (010-83575252, wucaixia314@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with 18F-G1-related adverse events (AEs). (time frame: 3 days after the injection of 18F-G1). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.