Marginal Zone LymphomaPhase 3LYMFORNCT06125028
[68Ga]Ga-PentixaFor-PET Imaging for Staging of Marginal Zone Lymphoma
A Phase 3 study testing [68Ga]Ga-PentixaFor and [18F]Fluorodeoxyglucose in people with Marginal Zone Lymphoma, run by Pentixapharm AG at 12 sites in 5 countries.
Trial summary
This will be a pivotal prospective prospective, international, multi-center, comparative, randomized, cross-over, open-label lymphoma diagnostic trial to assess the diagnostic performance and safety of the positron emission tomography (PET) imaging agent [68Ga]Ga-PTF) , versus [18F]FDG PET/CT imaging, for staging of… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Marginal Zone Lymphoma
- What is being tested?
- [68Ga]Ga-PentixaFor and [18F]Fluorodeoxyglucose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 12 sitesin 5 countries
- Study dates
- 20 May 2024to 18 Jul 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients must meet all of the following criteria:
- Signed informed consent from the patient.
- Patients of either gender, aged ≥ 18 years.
- Patients with a histologically proven diagnosis of marginal zone lymphoma (MZL) according to the World Health Organization (WHO) classification of lymphoid neoplasms. Patients must have a biopsy-proven nodal, extranodal, or splenic MZL (at the time of enrolment, the CXCR4 expression status will be unknown).
- Treatment-naïve.
- Negative pregnancy test in women capable of child-bearing and their agreement to use highly effective contraception for 1 month after the last dose of [68Ga]Ga-PTF and [18F]FDG.
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- For male patients whose partner is of child-bearing potential: The patient is willing to ensure that he and his partner use effective contraception for 1 month after the last dose of [68Ga]Ga-PTF and [18F]FDG.
- Acceptable organ function, as evidenced by the following laboratory data:
- No renal impairment: Estimated glomerular filtration rate (eGFR) > 30 mL/min/1.73 m2or creatinine clearance > 60 mL/min by the Cockcroft-Gault equation or equivalent
- Total bilirubin ≤ 1.5 × ULN (upper limit of normal)
- Serum albumin ≥ 2.5 g/dL.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN or ≤ 5 × ULN in the presence of liver metastases
- International normalized ratio (INR) < 1.3 or ≤ institutional ULN.
- Life expectancy ≥ 12 weeks as estimated by the Investigator.
- The patient must not have undergone any physical or pharmacological intervention with curative or palliative intent between the time of any of the diagnostic measures and the [68Ga]Ga-PTF PET/CT and [18F]FDG PET/CT scan.
Who cannot join
- Patients will be excluded if one or more of the following criteria are met:
- Known hypersensitivity to any active pharmaceutical agent or constituent of the [68Ga]Ga-PTF and/or [18F]FDG investigational products.
- Inability to lie still for the entire imaging time.
- Any severe acute or active chronic infection, as judged by the Investigator, at the time of screening or within two months prior to screening that may interfere with the diagnostic properties of [68Ga]Ga-PTF PET/CT and/or [18F]FDG PET/CT imaging.
- Patients with plasma glucose levels higher than 11 mmol/L or 200 mg/dL prior to [18F]FDG administration.
- Administration of any anti-cancer therapy within 1 month prior to study entry.
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- Patients with complete resection of all tumor lesion(s).
- Administration of another investigational medicinal product within 30 days or within 5 terminal elimination half-lives of previous investigational medicinal product, whichever is longer, prior to study entry.
- Current greater than grade 2 toxicity from any reason, per US-NCI "Common Terminology Criteria for Adverse Events v5.0" (NCI CTCAE 2017) except if tumor-related.
- Pregnant or breast-feeding women.
- Concomitant prohibited treatment which may interfere with [68Ga]Ga-PTF PET/CT imaging (systemic corticosteroids) administered within the last 1 month prior to study start.
- Colony-stimulating factor (CSF) therapy within 5 days prior to [18F]FDG PET/CT examination.
- Any recent myocardial infarction, stroke, or osteomyelitis within two months prior screening.
- [18F]FDG PET/CT imaging or [68Ga]Ga-PTF PET imaging performed prior to study entry.
- Judged by the referring physician as not mentally or as not physically fit to understand and comply with protocol-related interventions and procedures (e.g., medically retarded, body weight > 180 kg for PET scanner).
- Body weight of less than 48 kg.
- Any other concurrently active neoplasia, or other disease who could jeopardize study safety or data.
Trial locations and contacts
12 sites in 5 countries.
12 sites in 5 countries
France4 sites
CHU de Bordeaux
Bordeaux, 33600
CHU La Timone
Marseille, 13005
CHU de Nantes
Nantes, 44093
Hôpital Cochin
Paris, 75014
Italy4 sites
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
L'IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l
Meldola, 47014
Ospedale San Raffaele S.r.l.
Milan, 20132
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00168
Germany2 sites
Universitätsklinikum Essen
Essen, 45147
Universitätsklinikum Würzburg
Würzburg, 97080
About this study
Official title: A Pivotal Phase 3 Clinical Trial to Assess the Diagnostic Performance and Safety of [68Ga]Ga-PentixaFor ([68Ga]Ga-PTF), a Positron Emission Tomography (PET) Imaging Agent, Versus [18F]FDG PET/CT Imaging, for Staging of Patients With Confirmed Marginal Zone Lymphoma Exemplary for CXCR4-positive Malignant Lymphomas: a Prospective, International, Multi-center, Comparative, Randomized, Cross-over, Open-label Lymphoma Diagnostic Trial
This will be a pivotal prospective prospective, international, multi-center, comparative, randomized, cross-over, open-label lymphoma diagnostic trial to assess the diagnostic performance and safety of the positron emission tomography (PET) imaging agent [68Ga]Ga-PTF) , versus [18F]FDG PET/CT imaging, for staging of patients with confirmed marginal zone lymphoma exemplary for CXCR4-positive malignant lymphomas.
- Conditions
- Marginal Zone Lymphoma
- Being tested
- [68Ga]Ga-PentixaFor, [18F]Fluorodeoxyglucose
- Medical subject headings
- Lymphoma, B-Cell, Marginal Zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-PentixaForDrug
Also called [68Ga]Ga-PTF
[68Ga]Ga-PTF i.v. injection
[18F]FluorodeoxyglucoseDrug
Also called [18F]FDG
[18F]FDG i.v. injection.
| Study group | Role | What they receive |
|---|---|---|
| [68Ga]Ga-PTF PET/CT | Experimental | 150 (+/-50) MBq [68Ga]Ga-PTF will be administered intravenously and PET/CT will be performed Receives: Drug: [68Ga]Ga-PentixaFor |
| [18F]FDG PET/CT | Active comparator | [18F]FDG will be administered once intravenously according to the SMPC and PET/CT will be performed Receives: Drug: [18F]Fluorodeoxyglucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of [68Ga]Ga-PTF PET/CT imaging vs. [18F]FDG PET/CT imaging in tumor detection
Measured: Through study completion, an average of 6 months
Specificity of [68Ga]Ga-PTF PET/CT imaging vs. [18F]FDG PET/CT imaging in tumor detection
Measured: Through study completion, an average of 6 months
Secondary outcomes (32)
Proportion of patients with additional or less lesions detected by each PET/CT imaging agent ([68Ga]Ga-PTF and [18F]FDG) compared to pre-PET conventional staging as assessed by questionnaires completed by the referring physicians
Measured: Through study completion, an average of 6 months
Proportion of patients with a change in intended patient management due to additional or less lesions detected by each PET/CT imaging agent ([68Ga]Ga-PTF and [18F]FDG) as assessed by questionnaires completed by the referring physicians
Measured: Through study completion, an average of 6 months
Proportion of patients with additional or less lesions detected by each PET/CT imaging agent ([68Ga]Ga-PTF and [18F]FDG) compared to pre-PET conventional staging as assessed by questionnaires completed by an Independent Committee
Measured: Through study completion, an average of 6 months
Inter-observer agreement of local and central assessment in terms of staging
Measured: Through study completion, an average of 6 months
Proportion of patients with nodal MZL with additional or less lesions detected by each PET/CT imaging agent ([68Ga]Ga-PTF and [18F]FDG) compared to pre-PET conventional staging as assessed by questionnaires completed by the referring physicians
Measured: Through study completion, an average of 6 months
Proportion of patients with extranodal MZL with additional or less lesions detected by each PET/CT imaging agent ([68Ga]Ga-PTF and [18F]FDG) compared to pre-PET conventional staging as assessed by questionnaires completed by the referring physicians
Measured: Through study completion, an average of 6 months
Proportion of patients with splenic MZL with additional or less lesions detected by each PET/CT imaging agent ([68Ga]Ga-PTF and [18F]FDG) compared to pre-PET conventional staging as assessed by questionnaires completed by the referring physicians
Measured: Through study completion, an average of 6 months
Proportion of patients with nodal MZL with a change in intended patient management due to additional or less lesions detected by each PET/CT imaging agent ([68Ga]Ga-PTF and [18F]FDG) as assessed by questionnaires completed by the referring physicians
Measured: Through study completion, an average of 6 months
Proportion of patients with extranodal MZL with a change in intended patient management due to additional or less lesions detected by each PET/CT imaging agent ([68Ga]Ga-PTF;[18F]FDG) as assessed by questionnaires completed by the referring physicians
Measured: Through study completion, an average of 6 months
Proportion of patients with splenic MZL with a change in intended patient management due to additional or less lesions detected by each PET/CT imaging agent ([68Ga]Ga-PTF and [18F]FDG) as assessed by questionnaires completed by the referring physicians
Measured: Through study completion, an average of 6 months
Diagnostic performance, consisting of sensitivity and specificity, of each PET/CT imaging agent in tumor detection on a region-basis (eyes, ears, nose, throat, liver, spleen, gastrointestinal tract, bone marrow) confirmed by SoT or surrogate SoT
Measured: Through study completion, an average of 6 months
Sensitivity of each PET/CT imaging agent in tumor detection on a patient-basis confirmed by SoT or surrogate SoT
Measured: Through study completion, an average of 6 months
Positive and negative predictive values (PPV, NPV) of each PET/CT imaging agent to detect tumor on a patient-basis and lesion-basis
Measured: Through study completion, an average of 6 months
Detection rate of each PET/CT imaging agent to detect tumor on a patient-basis and lesion-basis confirmed by SoT or surrogate SoT
Measured: Through study completion, an average of 6 months
Proportion of patients with additional or less tumoral lesions detected by [68Ga]Ga-PTF PET/CT imaging compared to [18F]FDG PET/CT imaging
Measured: Through study completion, an average of 6 months
Inter-reader and intra-reader agreement for tumor detection of each PET/CT imaging agent on a lesion-basis and patient-basis
Measured: Through study completion, an average of 6 months
Reproducibility of [68Ga]Ga-PTF PET/CT imaging (reproducibility group)
Measured: Through study completion, an average of 6 months
Maximum standardized uptake value (SUVmax), SUVpeak and SUV mean of each PET/CT imaging agent
Measured: Through study completion, an average of 6 months
Target-to-background ratio (TBR) of each PET/CT imaging agent
Measured: Through study completion, an average of 6 months
Contrast-to-noise ratio (CNR) of each PET/CT imaging agent
Measured: Through study completion, an average of 6 months
Signal-to-noise ratio (CNR) of each PET/CT imaging agent
Measured: Through study completion, an average of 6 months
Frequency and Severity of Adverse Events for each PET/CT imaging agent
Measured: Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent
Frequency and kind of adverse effects present at the injection site
The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of the injection site status (which kind of adverse effects have appeared) after the injection of each PET/CT imaging compound
Measured: 2-3 hours after injection of each PET/CT imaging agent
Clinical significance of abnormal results during physical examination
The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of physical examination findings
Measured: Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent
Blood pressure (systolic and diastolic)
The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of blood pressure (systolic and diastolic)
Measured: Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent
Heart or pulse rate
The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of heart or pulse rate
Measured: Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent
RR interval findings/abnormalities
The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of findings/abnormalities in the RR interval
Measured: Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent
PQ interval findings/abnormalities
The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of PQ interval findings/abnormalities
Measured: Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent
QRS complex findings/abnormalities
The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of QRS complex findings/abnormalities
Measured: Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent
QT interval findings/abnormalities
The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of QT interval findings/abnormalities
Measured: Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent
QTc interval findings/abnormalities
The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of QTc interval findings/abnormalities
Measured: Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent
Weight
The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of patient weight
Measured: Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start20 May 2024
- Primary completion18 Jul 2025
- Study completion18 Jul 2025
Why it stopped: low recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marginal Zone 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pentixapharm AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pivotal S.L.
- Responsible party
- Sponsor
- Investigators
- Andreas Buck, Prof. Dr., Principal investigator, University Hospital Würzburg, Department of Nuclear Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125028
- Sponsor's protocol ID
- PTF301
- Acronym
- LYMFOR
- Status last verified
- Aug 2025
- First submitted
- 13 Oct 2023
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal Phase 3 Clinical Trial to Assess the Diagnostic Performance and Safety of [68Ga]Ga-PentixaFor ([68Ga]Ga-PTF), a Positron Emission Tomography (PET) Imaging Agent, Versus [18F]FDG PET/CT Imaging, for Staging of Patients With Confirmed Marginal Zone Lymphoma Exemplary for CXCR4-positive Malignant Lymphomas: a Prospective, International, Multi-center, Comparative, Randomized, Cross-over, Open-label Lymphoma Diagnostic Trial
- ClinicalTrials.gov ID
- NCT06125028
- Acronym / sponsor ID
- LYMFOR / PTF301
- Conditions
- Marginal Zone Lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low recruitment rate
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Pentixapharm AGIndustry (pharma, biotech, devices)
- Collaborators
- Pivotal S.L.
- Study start
- 20 May 2024 (actual)
- Primary completion
- 18 Jul 2025 (actual)
- Study completion
- 18 Jul 2025 (actual)
- First posted
- 9 Nov 2023 (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 will be a pivotal prospective prospective, international, multi-center, comparative, randomized, cross-over, open-label lymphoma diagnostic trial to assess the diagnostic performance and safety of the positron emission tomography (PET) imaging agent [68Ga]Ga-PTF) , versus [18F]FDG PET/CT imaging, for staging of patients with confirmed marginal zone lymphoma exemplary for CXCR4-positive malignant lymphomas.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| [68Ga]Ga-PTF PET/CT | Experimental | Drug: [68Ga]Ga-PentixaFor150 (+/-50) MBq [68Ga]Ga-PTF will be administered intravenously and PET/CT will be performed |
| [18F]FDG PET/CT | Active comparator | Drug: [18F]Fluorodeoxyglucose[18F]FDG will be administered once intravenously according to the SMPC and PET/CT will be performed |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Signed informed consent from the patient.
- Patients of either gender, aged ≥ 18 years.
- Patients with a histologically proven diagnosis of marginal zone lymphoma (MZL) according to the World Health Organization (WHO) classification of lymphoid neoplasms. Patients must have a biopsy-proven nodal, extranodal, or splenic MZL (at the time of enrolment, the CXCR4 expression status will be unknown).
- Treatment-naïve.
- Negative pregnancy test in women capable of child-bearing and their agreement to use highly effective contraception for 1 month after the last dose of [68Ga]Ga-PTF and [18F]FDG.
Key exclusion criteria (17 listed)
- Known hypersensitivity to any active pharmaceutical agent or constituent of the [68Ga]Ga-PTF and/or [18F]FDG investigational products.
- Inability to lie still for the entire imaging time.
- Any severe acute or active chronic infection, as judged by the Investigator, at the time of screening or within two months prior to screening that may interfere with the diagnostic properties of [68Ga]Ga-PTF PET/CT and/or [18F]FDG PET/CT imaging.
- Patients with plasma glucose levels higher than 11 mmol/L or 200 mg/dL prior to [18F]FDG administration.
- Administration of any anti-cancer therapy within 1 month prior to study entry.
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 |
|---|---|---|
| [68Ga]Ga-PentixaForAlso: [68Ga]Ga-PTF[68Ga]Ga-PTF i.v. injection | Drug | [68Ga]Ga-PTF PET/CT |
| [18F]FluorodeoxyglucoseAlso: [18F]FDG[18F]FDG i.v. injection. | Drug | [18F]FDG PET/CT |
Primary outcome
Sensitivity of [68Ga]Ga-PTF PET/CT imaging vs. [18F]FDG PET/CT imaging in tumor detection
Time frame: Through study completion, an average of 6 months
Specificity of [68Ga]Ga-PTF PET/CT imaging vs. [18F]FDG PET/CT imaging in tumor detection
Time frame: Through study completion, an average of 6 months
32 secondary outcomes
Proportion of patients with additional or less lesions detected by each PET/CT imaging agent ([68Ga]Ga-PTF and [18F]FDG) compared to pre-PET conventional staging as assessed by questionnaires completed by the referring physicians
Time frame: Through study completion, an average of 6 months
Proportion of patients with a change in intended patient management due to additional or less lesions detected by each PET/CT imaging agent ([68Ga]Ga-PTF and [18F]FDG) as assessed by questionnaires completed by the referring physicians
Time frame: Through study completion, an average of 6 months
Proportion of patients with additional or less lesions detected by each PET/CT imaging agent ([68Ga]Ga-PTF and [18F]FDG) compared to pre-PET conventional staging as assessed by questionnaires completed by an Independent Committee
Time frame: Through study completion, an average of 6 months
Inter-observer agreement of local and central assessment in terms of staging
Time frame: Through study completion, an average of 6 months
Proportion of patients with nodal MZL with additional or less lesions detected by each PET/CT imaging agent ([68Ga]Ga-PTF and [18F]FDG) compared to pre-PET conventional staging as assessed by questionnaires completed by the referring physicians
Time frame: Through study completion, an average of 6 months
Proportion of patients with extranodal MZL with additional or less lesions detected by each PET/CT imaging agent ([68Ga]Ga-PTF and [18F]FDG) compared to pre-PET conventional staging as assessed by questionnaires completed by the referring physicians
Time frame: Through study completion, an average of 6 months
Proportion of patients with splenic MZL with additional or less lesions detected by each PET/CT imaging agent ([68Ga]Ga-PTF and [18F]FDG) compared to pre-PET conventional staging as assessed by questionnaires completed by the referring physicians
Time frame: Through study completion, an average of 6 months
Proportion of patients with nodal MZL with a change in intended patient management due to additional or less lesions detected by each PET/CT imaging agent ([68Ga]Ga-PTF and [18F]FDG) as assessed by questionnaires completed by the referring physicians
Time frame: Through study completion, an average of 6 months
Proportion of patients with extranodal MZL with a change in intended patient management due to additional or less lesions detected by each PET/CT imaging agent ([68Ga]Ga-PTF;[18F]FDG) as assessed by questionnaires completed by the referring physicians
Time frame: Through study completion, an average of 6 months
Proportion of patients with splenic MZL with a change in intended patient management due to additional or less lesions detected by each PET/CT imaging agent ([68Ga]Ga-PTF and [18F]FDG) as assessed by questionnaires completed by the referring physicians
Time frame: Through study completion, an average of 6 months
Diagnostic performance, consisting of sensitivity and specificity, of each PET/CT imaging agent in tumor detection on a region-basis (eyes, ears, nose, throat, liver, spleen, gastrointestinal tract, bone marrow) confirmed by SoT or surrogate SoT
Time frame: Through study completion, an average of 6 months
Sensitivity of each PET/CT imaging agent in tumor detection on a patient-basis confirmed by SoT or surrogate SoT
Time frame: Through study completion, an average of 6 months
Positive and negative predictive values (PPV, NPV) of each PET/CT imaging agent to detect tumor on a patient-basis and lesion-basis
Time frame: Through study completion, an average of 6 months
Detection rate of each PET/CT imaging agent to detect tumor on a patient-basis and lesion-basis confirmed by SoT or surrogate SoT
Time frame: Through study completion, an average of 6 months
Proportion of patients with additional or less tumoral lesions detected by [68Ga]Ga-PTF PET/CT imaging compared to [18F]FDG PET/CT imaging
Time frame: Through study completion, an average of 6 months
Inter-reader and intra-reader agreement for tumor detection of each PET/CT imaging agent on a lesion-basis and patient-basis
Time frame: Through study completion, an average of 6 months
Reproducibility of [68Ga]Ga-PTF PET/CT imaging (reproducibility group)
Time frame: Through study completion, an average of 6 months
Maximum standardized uptake value (SUVmax), SUVpeak and SUV mean of each PET/CT imaging agent
Time frame: Through study completion, an average of 6 months
Target-to-background ratio (TBR) of each PET/CT imaging agent
Time frame: Through study completion, an average of 6 months
Contrast-to-noise ratio (CNR) of each PET/CT imaging agent
Time frame: Through study completion, an average of 6 months
Signal-to-noise ratio (CNR) of each PET/CT imaging agent
Time frame: Through study completion, an average of 6 months
Frequency and Severity of Adverse Events for each PET/CT imaging agent
Time frame: Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent
Frequency and kind of adverse effects present at the injection site
Time frame: 2-3 hours after injection of each PET/CT imaging agent
Clinical significance of abnormal results during physical examination
Time frame: Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent
Blood pressure (systolic and diastolic)
Time frame: Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent
Heart or pulse rate
Time frame: Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent
RR interval findings/abnormalities
Time frame: Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent
PQ interval findings/abnormalities
Time frame: Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent
QRS complex findings/abnormalities
Time frame: Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent
QT interval findings/abnormalities
Time frame: Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent
QTc interval findings/abnormalities
Time frame: Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent
Weight
Time frame: Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent
Results and safety
The study was stopped early (reason given: low recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
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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. This study is not recruiting at the moment.
Andreas Buck, Prof. Dr. principal investigator
University Hospital Würzburg, Department of Nuclear Medicine
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing [68Ga]Ga-PentixaFor and [18F]Fluorodeoxyglucose in people with Marginal Zone Lymphoma, run by Pentixapharm AG at 12 sites in 5 countries.
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 15 inclusion and 17 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: stopped early, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France, Italy, Germany, Austria, Spain. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: low recruitment rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of [68Ga]Ga-PTF PET/CT imaging vs. [18F]FDG PET/CT imaging in tumor detection (time frame: Through study completion, an average of 6 months). The study lists 2 primary outcomes in all. 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 28 Apr 2026.