68Ga-JH12 PET/CT: Dosimetry and Biodistribution Study

NCT ID: NCT06688188

Last Updated: 2024-11-14

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

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-12-31

Brief Summary

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68Ga-JH12 is a novel radiotracer targeting C-X-C motif chemokine receptor 4 (CXCR4). In this study, we observed the safety, biodistribution, and radiation dosimetry of 68Ga-JH12 in patients with different types of cancer.

Detailed Description

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C-X-C motif chemokine receptor 4 (CXCR4) is highly expressed in patients affected with malignant tumors and ex-vivo analyses provided evidence that the expression level on the tumor cell surface is tightly linked to the proliferation index. In recent years, the diagnostic PET agent 68Ga-Pentixafor targeting this chemokine receptor has been extensively validated in haematological malignancies and solid tumors. 68Ga-JH12, a novel radiopharmaceutical targeting CXCR4, demostrated high stability in vitro and in vivo, and can accumulate specifically in tumors with high binding affinity, safety, and selectivity in preclinical studies. In this study, the safety, biodistribution, and radiation dosimetry of 68Ga-JH12 in patients with Various Cancers were observed to evaluate the dosimetric characteristics of 68Ga-JH12.

Conditions

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Malignant Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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dynamic PET scans

PET imaging will begin at 3 minutes, 15 minutes, 30min minutes, 60 minutes and 150 minutes after injection.

Group Type EXPERIMENTAL

68Ga-JH12

Intervention Type DRUG

The dose will be 148-222 MBq given intravenously.

Interventions

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68Ga-JH12

The dose will be 148-222 MBq given intravenously.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Various solid tumors with available histopathological findings
* Signed informed consent

Exclusion Criteria

* pregnant or lactational women
* who suffered from severe hepatic and renal insufficiency
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Weibing Miao, MD

Role: CONTACT

+86-0591-87981618

Guochang Wang, MD

Role: CONTACT

+86-0591-87981619

Facility Contacts

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Weibing Miao, MD

Role: primary

+86-0591 87981618

Guochang Wang, MD

Role: backup

+86-0591 87981619

Other Identifiers

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FirstAHFujian-68Ga-JH12

Identifier Type: -

Identifier Source: org_study_id

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