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

NCT ID: NCT05000372

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-22

Study Completion Date

2024-05-31

Brief Summary

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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.

Detailed Description

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The investigators recently developed a granzyme B-specific radiotracer named 68Ga-grazytracer. This clinical trial aims to investigate whether granzyme B PET imaging using 68Ga-grazytracer could early identify tumor responses to immune checkpoint inhibitory therapy or CAR-T therapy in subjects with solid tumor and lymphoma. PET/CT imaging of 68Ga-grazytracer will be performed in subjects after immunotherapy.

Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Single Group Assignment
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Feasibility and safety of 68Ga-grazytracer

The purpose of the study is to evaluate the safety and early predictive performance of 68Ga-grazytracer for immunotherapy.

Group Type EXPERIMENTAL

68Ga-grazytracer

Intervention Type DRUG

68Ga-grazytracer PET/CT: after intravenous injection of 2.96-3.7 MBq/kg body weight of quality-controlled 68Ga-grazytracer, a Biograph mCT Flow 64 scanner or Total-body PET/CT uEXPLORER scanner will be applied, and the scan range will be from the top of the head to 1/3 of the upper thigh.

Interventions

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68Ga-grazytracer

68Ga-grazytracer PET/CT: after intravenous injection of 2.96-3.7 MBq/kg body weight of quality-controlled 68Ga-grazytracer, a Biograph mCT Flow 64 scanner or Total-body PET/CT uEXPLORER scanner will be applied, and the scan range will be from the top of the head to 1/3 of the upper thigh.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Health Science Center

OTHER

Sponsor Role collaborator

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nan Li, M.D.

Role: STUDY_DIRECTOR

Peking University Cancer Hospital & Institute

Zhaofei Liu, Ph.D.

Role: STUDY_DIRECTOR

Peking University

Zhi Yang, Ph.D.

Role: STUDY_DIRECTOR

Peking University Cancer Hospital & Institute

Locations

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Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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Shen X, Zhou H, Zhou X, Liu Z, Meng X, Zhang L, Song Y, Guo R, Wang F, Li K, Li W, Yang Z, Liu Z, Li N. 68Ga-grazytracer PET for noninvasive assessment of response to immunotherapy in solid tumors and lymphomas: a phase 1/2 clinical trial. Nat Commun. 2024 Oct 10;15(1):8791. doi: 10.1038/s41467-024-53197-2.

Reference Type DERIVED
PMID: 39389969 (View on PubMed)

Zhou H, Wang Y, Xu H, Shen X, Zhang T, Zhou X, Zeng Y, Li K, Zhang L, Zhu H, Yang X, Li N, Yang Z, Liu Z. Noninvasive interrogation of CD8+ T cell effector function for monitoring early tumor responses to immunotherapy. J Clin Invest. 2022 Aug 15;132(16):e161065. doi: 10.1172/JCI161065.

Reference Type DERIVED
PMID: 35788116 (View on PubMed)

Other Identifiers

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2021KT86

Identifier Type: -

Identifier Source: org_study_id