CompletedPhase 1/2

68Ga-grazytracer PET/CT of Tumor Responses to Immunotherapy

China24 participantsStarted 2021-09-22

Plain-language summary

This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the safety and clinical predictive value of 68Ga-grazytracer in subjects with solid tumor or lymphoma receiving immunotherapy.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Participants who were diagnosed with malignant tumors;
. Patients who were scheduled to receive immunotherapy based on a decision made by a multidisciplinary team;
. participants who had no prior immunotherapy;
. participants who had no regional therapy within 3 months;
. Participants aged ≥18 years.

Exclusion criteria

. participants with a concurrent disease that would impede the treatment regimen;
. Participants who were unable or unwilling to provide written informed consent.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of 68Ga-grazytracer-emergent Adverse Events

Timeframe: 3 year

Biodistribution of 68Ga-grazytracer

Timeframe: 3 year

Analyzing the in vivo granzyme B-specificity of 68Ga-grazytracer

Timeframe: 3 year

Assessing the early predictive value of 68Ga-grazytracer for immunotherapy response

Timeframe: 3 year

Trial details

NCT IDNCT05000372

SponsorPeking University Cancer Hospital & Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-25

View on ClinicalTrials.gov More Cancer trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Participants who were diagnosed with malignant tumors;
. Patients who were scheduled to receive immunotherapy based on a decision made by a multidisciplinary team;
. participants who had no prior immunotherapy;
. participants who had no regional therapy within 3 months;
. Participants aged ≥18 years.

Exclusion criteria

. participants with a concurrent disease that would impede the treatment regimen;
. Participants who were unable or unwilling to provide written informed consent.

What they're measuring

Incidence of 68Ga-grazytracer-emergent Adverse Events

Timeframe: 3 year

Biodistribution of 68Ga-grazytracer

Timeframe: 3 year

Analyzing the in vivo granzyme B-specificity of 68Ga-grazytracer

Timeframe: 3 year

Assessing the early predictive value of 68Ga-grazytracer for immunotherapy response

Timeframe: 3 year