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

June 11, 2024 updated by: Koo Foundation Sun Yat-Sen Cancer Center

Ga-68-CXCR4 PET/CT in Detecting, Evaluating Response to Treatment, and Monitoring Risk of Aggressiveness of Indolent B-cell Lymphoma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yu Yi Huang, MD
  • Phone Number: 1121 +886 28970011
  • Email: yuyi@kfsyscc.org

Study Contact Backup

Study Locations

  • Taiwan
    • Beitou
      • Taipei, Beitou, Taiwan, 1125019
        • Recruiting
        • Koo Foundation Sun Yat-Sen Cancer Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Ga-68-CXCR4
Ga-68-CXCR4 for PET/CT procedure in Indolent B-cell Lymphoma
Other Names:
  • PET/CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance of Ga-68-CXCR4 PET/CT in indolent B cell lymphoma
Time Frame: up to 24 months
Detection rate = number of positive scan / total number of scan Sensitivity = number of true positive scan / total number of proven recurrent patient Specificity = number of true negative scan / total number of proven free of disease patient Accuracy = number of (true positive scan + true negative scan) / total number of scan Positive predictive value = number of true positive scan / number of positive scan Negative predictive value = number of true negative scan / number of negative scan
up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ga-68-CXCR4 compared to F-18-FDG PET/CT
Time Frame: up to 24 months
McNemar test, Two-tailed，P<.05
up to 24 months
Clinical impact of Ga-68-CXCR4 compared to F-18-FDG PET/CT
Time Frame: up to 24 months
Treatment plan questionnaires before and after Ga-68-CXCR4 PET/CT
up to 24 months
Prognostic value of Ga-68-CXCR4 PET/CT scan
Time Frame: up to 36 months

The correlation between the radiomic features of Ga-68-CXCR4 PET/CT scan and progression free survival.

CXCR4 radiomics : Feature extraction was performed with the open-source Python package pyradiomics. For each volume of interest (VOI), including first-order statistics, shape features, grey level co-occurrence matrix (GLCM), grey level run length matrix (GLRLM), grey level size-zone matrix (GLSZM), neighborhood grey level different matrix (NGLDM), and grey level dependence matrix (GLDM).
up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Koo Foundation Sun Yat-Sen Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

May 23, 2024

First Submitted That Met QC Criteria

June 11, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

June 14, 2024

Last Update Submitted That Met QC Criteria

June 11, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KF-CXCR4-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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