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

Indolent B-Cell Non-Hodgkin Lymphoma Clinical Trial

— PentixaFor  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06461182
• Other study ID #: KF-CXCR4-001
• Status: Recruiting
• Phase: Phase 2
• Start date: April 29, 2024
• Est. completion date: April 2027

Study information

• Verified date: June 2024
• Source: Koo Foundation Sun Yat-Sen Cancer Center
• Contact: Yu Yi Huang, MD
• Phone: +886 28970011
• Email: yuyi[@]kfsyscc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: April 2027
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Indolent B-Cell Non-Hodgkin Lymphoma
• Lymphoma
• Lymphoma, B-Cell

Intervention

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

Locations

Country	Name	City	State
Taiwan	Koo Foundation Sun Yat-Sen Cancer Center	Taipei	Beitou

Sponsors (1)

Lead Sponsor	Collaborator
Koo Foundation Sun Yat-Sen Cancer Center

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ga-68-CXCR4 compared to F-18-FDG PET/CT	McNemar test, Two-tailed,P<.05	up to 24 months
Secondary	Clinical impact of Ga-68-CXCR4 compared to F-18-FDG PET/CT	Treatment plan questionnaires before and after Ga-68-CXCR4 PET/CT	up to 24 months
Secondary	Prognostic value of Ga-68-CXCR4 PET/CT scan	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