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

NCT06461182 | Recruiting Phase 2

• 1 other identifier: KF-CXCR4-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Indolent B-Cell Non-Hodgkin Lymphoma

Keywords

Ga-68-CXCR4 PET/CT; indolent B-cell lymphoma

Outcome Measures

Primary Outcomes (1)

• Performance of Ga-68-CXCR4 PET/CT in indolent B cell lymphoma

  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 Outcomes (3)

• Ga-68-CXCR4 compared to F-18-FDG PET/CT

  up to 24 months

• Clinical impact of Ga-68-CXCR4 compared to F-18-FDG PET/CT

  up to 24 months

• Prognostic value of Ga-68-CXCR4 PET/CT scan

  up to 36 months

Study Arms (1)

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

EXPERIMENTAL

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

Drug: Ga-68-CXCR4

Interventions

Ga-68-CXCR4 DRUG

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

Also known as: PET/CT

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

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Koo Foundation Sun Yat-Sen Cancer Center: lead

Study Sites (1)

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, Beitou, 1125019, Taiwan

RECRUITING

Central Study Contacts

Yu Yi Huang, MD

CONTACT

+886 28970011; yuyi@kfsyscc.org

Cheng Ling Yang, B.Rad.

CONTACT

+886 28970011; androgyny@kfsyscc.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: June 14, 2024
• Study Start: April 29, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 14, 2024

Record last verified: 2024-06

Locations

TW (1)