ClinicalTrials.gg
RecruitingNCT07039474Updated Sep 28, 2026

The Application of 18F-G1 PET/CT Targeting Granzyme B in the Pan-cancer Immunotherapy

An observational study in Solid Tumor Malignancies, Hematologic Cancer and Lung Cancer, sponsored by Peking University First Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Peking University First Hospital · Observational

From the registry’s dates

  • Started Sep 2026; still recruiting 2 months later.
Updated Sep 28, 2026Now RecruitingFirst site in China+5 moreGo to Updates ↓

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 148 studies in Hematologic Neoplasms with a site in China — 75 open to participants now, 83 under way, 8 of them phase 3. Hematologic Neoplasms · China.

Planned enrollment
10th of 24
120 · median 88
Started
2026
with 19 others
Observational
24 of 148
13 open now
Primary completion
2028-12
later than 69 of 82 live
Registered
116th of 148
by date

Among the 148 studies in Hematologic Neoplasms with a site in China, this one is the 10th largest by planned enrollment of the 24 observational ones that give a count, is one of 20 that started in 2026, is one of 24 observational ones, reaches primary completion later than 69 of the 82 other live ones, and was the 116th registered.

Hematologic Neoplasms

1,444 studies on the registry are indexed under Hematologic Neoplasms; 420 are open to participants now.

Browse Hematologic Neoplasms studies →

Open to participants now

75 of the 148 studies in Hematologic Neoplasms with a site in China are open now. Recruiting first, the newest first:

69 more — sign in →

All 75 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 313 Hematologic Neoplasms studies recruiting now, 208 (66%) set no upper age limit and 78 (25%) stop at 75 or younger; 80 take children under 18; 34 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 148 studies in Hematologic Neoplasms with a site in China, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Solid Tumor Malignancies
  • Hematologic Cancer
  • Lung Cancer
  • Esophagus Cancer
  • Breast Cancer
  • Kidney Cancer
  • Stomach Cancer
  • Lymphoma
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

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).

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. Subjects diagnosed with a malignant tumor by histopathology who are going to receive immunotherapy (monotherapy or combined immunotherapy) recommended by the multidisciplinary team.
  2. Subjects didn't receive previous immunotherapy.
  3. There exists at least one measurable target lesion according to the 1.1.
  4. performance status≤2.
  5. The expected survival time is ≥6 months.
  6. Effective measures will be adopted during the study period and within 6 months after the study.
  7. Willing and able to fully understand and sign the form.

Exclusion criteria

Exclusion Criteria:

  1. Women in the preconception period, pregnancy, or lactation period.
  2. Combined with other malignant tumor.
  3. Diagnosed with disease, or have long history of systemic hormone therapy or therapy.
  4. Having a history of severe cardiovascular disease, severe hepatic and renal insufficiency.
  5. Receiving radiotherapy or interventional therapy during the immunotherapy.
  6. 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.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

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

Interventions

  • Drug18F-G1

    18F-G1 is injected intravenously with a dose of 0.06-0.08mCi/kg

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 days after the injection of 18F-G1

  2. Tumor uptake of 18F-G1

    The uptake of 18F-G1 in tumors will be quantitatively assessed by SUVmax.

    Time frame: 40-60 minutes after the injection of 18F-G1

  3. Liver uptake of 18F-G1

    The uptake of 18F-G1 in liver will be quantitatively assessed by SUVmax.

    Time frame: 40-60 minutes after the injection of 18F-G1

  4. Lung uptake of 18F-G1

    The uptake of 18F-G1 in lung will be quantitatively assessed by SUVmax.

    Time frame: 40-60 minutes after the injection of 18F-G1

  5. Kidney uptake of 18F-G1

    The uptake of 18F-G1 in kidney will be quantitatively assessed by SUVmax.

    Time frame: 40-60 minutes after the injection of 18F-G1

  6. the granzyme B specificity of 18F-G1

    Time frame: 3 years

  7. 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.

    Time frame: 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.

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar 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 Sep 2026 (actual). Primary completion is estimated for Dec 2028, 26 months after the start.

Of 164 non-industry observational studies under Hematologic Neoplasms, half reached primary completion within 74 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 322. This study's planned 26 months is below that.

Counting every sponsor, half of 186 studies reached it within 74 months; a quarter within 34 and three quarters within 322.

Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 28, 2026: start Jul 2025 → Sep 2026, primary completion Dec 2026 → Dec 2028 and completion Jun 2027 → Dec 2028.

Earlier changes are on the record history on ClinicalTrials.gov ↗

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

Registered
May 26, 2025
First posted
Jun 26, 2025
StartActual
Sep 8, 2026was Jul 2025
Primary completionEst.
Dec 1, 2028was Dec 2026
CompletionEst.
Dec 15, 2028was Jun 2027
Last update
Sep 28, 2026
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.
Status
Not yet recruiting→Recruiting
changed Sep 28, 2026
Sites
1 site added — first site in China
Show site
  • Peking University First Hospital · Beijing, China
Sep 28, 2026
Start date
Jul 15, 2025→Sep 8, 2026 (actual)
Sep 28, 2026
Primary completion
Dec 31, 2026→Dec 1, 2028
Sep 28, 2026
Study completion
Jun 1, 2027→Dec 15, 2028
Sep 28, 2026
Primary outcomes
4 added, 1 removed
What changed in the outcomes
  • AddedTumor uptake of 18F-G1Time frame: 40-60 minutes after the injection of 18F-G1
  • AddedLiver uptake of 18F-G1Time frame: 40-60 minutes after the injection of 18F-G1
  • AddedLung uptake of 18F-G1Time frame: 40-60 minutes after the injection of 18F-G1
  • AddedKidney uptake of 18F-G1Time frame: 40-60 minutes after the injection of 18F-G1
  • RemovedThe vivo accumulation and distribution of 18F-G1 in tumors and major healthy organs.Time frame: 40-60 minutes after the injection of 18F-G1
Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    Not yet recruiting→Recruiting
    1 site added — first site in China
    Show site
    • Peking University First Hospital · Beijing, China
    Start date Jul 15, 2025→Sep 8, 2026 (now actual)
    Primary completion Dec 31, 2026→Dec 1, 2028
    Study completion Jun 1, 2027→Dec 15, 2028
    Primary outcomes 4 added, 1 removed
    What changed in the outcomes
    • AddedTumor uptake of 18F-G1Time frame: 40-60 minutes after the injection of 18F-G1
    • AddedLiver uptake of 18F-G1Time frame: 40-60 minutes after the injection of 18F-G1
    • AddedLung uptake of 18F-G1Time frame: 40-60 minutes after the injection of 18F-G1
    • AddedKidney uptake of 18F-G1Time frame: 40-60 minutes after the injection of 18F-G1
    • RemovedThe vivo accumulation and distribution of 18F-G1 in tumors and major healthy organs.Time frame: 40-60 minutes after the injection of 18F-G1
    + 3 other changes: index terms, verification date and conditions

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07039474
Responsible party
Sponsor
First posted
Jun 26, 2025
Start date
Sep 8, 2026
Primary completion
Dec 1, 2028 (estimated)
Completion
Dec 15, 2028 (estimated)
Last update
Sep 28, 2026

Study contacts

Caixia Wu
Contact
wucaixia314@163.com
010-83575252

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion