Indolent B-Cell Non-Hodgkin LymphomaPhase 2PentixaForNCT06461182
Ga-68-CXCR4 PET/CT in Indolent B-cell Lymphoma
A Phase 2 study testing Ga-68-CXCR4 in people with Indolent B-Cell Non-Hodgkin Lymphoma, run by Koo Foundation Sun Yat-Sen Cancer Center at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Indolent B-Cell Non-Hodgkin Lymphoma
- What is being tested?
- Ga-68-CXCR4
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Apr 2024to Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, Beitou, 1125019
Yu Yi Huang, MD, +886 28970011 ext. 1121, yuyi@kfsyscc.org
Cheng Ling Yang, B.Rad., +886 28970011 ext. 1167, androgyny@kfsyscc.org
About this study
Official title: 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.
- Conditions
- Indolent B-Cell Non-Hodgkin Lymphoma
- Being tested
- Ga-68-CXCR4
- Keywords
- Ga-68-CXCR4 PET/CT, indolent B-cell lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ga-68-CXCR4Drug
Also called PET/CT
Ga-68-CXCR4 for PET/CT procedure in Indolent B-cell Lymphoma
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ga-68-CXCR4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 24 months
Secondary outcomes (3)
Ga-68-CXCR4 compared to F-18-FDG PET/CT
McNemar test, Two-tailed，P<.05
Measured: up to 24 months
Clinical impact of Ga-68-CXCR4 compared to F-18-FDG PET/CT
Treatment plan questionnaires before and after Ga-68-CXCR4 PET/CT
Measured: up to 24 months
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).
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start29 Apr 2024
- Primary completionApr 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indolent B-Cell Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koo Foundation Sun Yat-Sen Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461182
- Sponsor's protocol ID
- KF-CXCR4-001
- Acronym
- PentixaFor
- Status last verified
- Jun 2024
- First submitted
- 23 May 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ga-68-CXCR4 PET/CT in Detecting, Evaluating Response to Treatment, and Monitoring Risk of Aggressiveness of Indolent B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT06461182
- Acronym / sponsor ID
- PentixaFor / KF-CXCR4-001
- Conditions
- Indolent B-Cell Non-Hodgkin Lymphoma
- Keywords
- Ga-68-CXCR4 PET/CT, indolent B-cell lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Koo Foundation Sun Yat-Sen Cancer CenterUniversity, hospital or other
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ga-68-CXCR4 PET/CT in Indolent B-cell Lymphoma | Experimental | Drug: Ga-68-CXCR4Indolent B-cell Lymphoma such as marginal-zone B-cell lymphoma、Waldenstrom macroglobulinemia lymphocytic lymphoma、CLL/SLL、mantle cell lymphoma. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ga-68-CXCR4Also: PET/CTGa-68-CXCR4 for PET/CT procedure in Indolent B-cell Lymphoma | Drug | Ga-68-CXCR4 PET/CT in Indolent B-cell Lymphoma |
Primary outcome
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
3 secondary outcomes
Ga-68-CXCR4 compared to F-18-FDG PET/CT
Time frame: up to 24 months
Clinical impact of Ga-68-CXCR4 compared to F-18-FDG PET/CT
Time frame: up to 24 months
Prognostic value of Ga-68-CXCR4 PET/CT scan
Time frame: up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ga-68-CXCR4 in people with Indolent B-Cell Non-Hodgkin Lymphoma, run by Koo Foundation Sun Yat-Sen Cancer Center at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Yi Huang, MD (+886 28970011 ext. 1121, yuyi@kfsyscc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of Ga-68-CXCR4 PET/CT in indolent B cell lymphoma (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.