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 range18 Years – 75 Years

SexALL

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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

Trial details

NCT IDNCT05000372

SponsorPeking University Cancer Hospital & Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-25

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