Ga-68-CXCR4 PET/CT in Indolent B-cell Lymphoma

NCT ID: NCT06461182

Last Updated: 2024-06-14

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

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-29

Study Completion Date

2027-04-30

Brief Summary

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This study explores the efficacy of Ga-68-PentixaFor PET/CT in detecting, assessing treatment response, and monitoring the risk of aggressiveness in indolent B-cell lymphoma. The background introduces CXCR4 and discusses its role in cancer research. Currently, FDG-PET is the primary imaging tool for lymphoma staging, but it lacks diagnostic accuracy for low-grade lymphomas. Ga-68-PentixaFor PET demonstrates promising detection capabilities across various lymphomas, suggesting its potential as a superior imaging modality for low-grade lymphomas.

Detailed Description

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Conditions

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Indolent B-Cell Non-Hodgkin Lymphoma

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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Ga-68-CXCR4 PET/CT in Indolent B-cell Lymphoma

Indolent B-cell Lymphoma such as marginal-zone B-cell lymphoma、Waldenstrom macroglobulinemia lymphocytic lymphoma、CLL/SLL、mantle cell lymphoma.

Group Type EXPERIMENTAL

Ga-68-CXCR4

Intervention Type DRUG

Ga-68-CXCR4 for PET/CT procedure in Indolent B-cell Lymphoma

Interventions

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Ga-68-CXCR4

Ga-68-CXCR4 for PET/CT procedure in Indolent B-cell Lymphoma

Intervention Type DRUG

Other Intervention Names

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PET/CT

Eligibility Criteria

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Inclusion Criteria

* The pathological diagnosis is slow-growing lymphoma, such as: marginal-zone B-cell lymphoma, Waldenstrom macroglobulinemia lymphocytic lymphoma, CLL/SLL, mantle cell lymphoma.
* Have undergone or planned to undergo FDG PET scan for indications including initial staging, therapeutic response evaluation, or follow-up examinations within 3 to 6 months in the clinical observation group.
* Able to lie flat for at least 30 minutes.
* Signing the subject consent form.
* ECOG grade 0-2.
* The timing of F-18-FDG usage in this trial follows the "Lymphoma Treatment Principles" of our institution.

Exclusion Criteria

* Pregnant woman
* Severe renal impairment (eGRF\< 30ml/min)
* Known or suspected allergy to radiopharmaceuticals
* Concurrent or previous diagnosis of malignancies other than lymphoma
* Inability to undergo the necessary PET scan procedure
* Refusal or unwillingness to sign the informed consent form
* Severe medical conditions (severe disabilities, mental disorders)
Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Koo Foundation Sun Yat-Sen Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Koo Foundation Sun Yat-Sen Cancer Center

Taipei, Beitou, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yu Yi Huang, MD

Role: CONTACT

+886 28970011 ext. 1121

Cheng Ling Yang, B.Rad.

Role: CONTACT

+886 28970011 ext. 1167

Facility Contacts

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Yu Yi Huang, MD

Role: primary

+886 28970011 ext. 1121

Cheng Ling Yang, B.Rad.

Role: backup

+886 28970011 ext. 1167

Other Identifiers

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KF-CXCR4-001

Identifier Type: -

Identifier Source: org_study_id

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