Neoplasms

Symptoms and General Pathology

All Conditions

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Neoplasm Metastasis

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Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Primary Central Nervous System Lymphoma

150 (+/-50) Megabecquerel (MBq) 68Ga-PTF will be injected intravenously at three timepoints during the course of the standard of care treatment.

68Ga-PTF will be injected intravenously at three time points during the course of the standard treatment of the patient.

68Ga-PTF

This will be an open, single-arm, international, multicentre, phase II imaging study to assess the predictive value of \[68Ga\]Ga PentixaFor PET imaging in primary and isolated secondary central nervous system lymphoma (CNSL) patients scheduled to undergo induction chemotherapy.

[68Ga]Ga-PentixaFor PET Imaging in CNS Lymphoma Patients

A Prospective, International, Multi-centre, Open-label, Single-arm Phase II Study Investigating the Predictive Value of [68Ga]Ga PentixaFor PET Imaging in Primary and Isolated Secondary CNS Lymphoma Patients

68Ga-PTF PET negativity for CXCR4 will be determined by visual analysis in central reading. For PFS assessment (yes/no variable), tumour progression or relapse will be determined according to the IPCG response criteria (Abrey et al. 2005) for the time period starting at baseline and ending at approx. 12 months after induction chemotherapy completion.

The negative predictive value is defined as follows: Number of patients without tumour progression or relapse / number of patients with interim 68Ga-PTF PET assessed as CXCR4-negative by central reviewer. The proportion obtained will be multiplied by 100 to obtain a percentage value.

This NPV will be calculated for the entire study population and also stratified by induction chemotherapy regimen (HD-MTX-based, DeVIC/ICE, HD-AraC-based regimen).

68Ga-PTF PET positivity for CXCR4 will be determined by visual analysis in central reading. For PFS assessment (yes/no variable), tumour progression or relapse will be determined according to the IPCG response criteria (Abrey et al. 2005) for the time period starting at baseline and ending at approx. 12 months after induction chemotherapy completion.

The positive predictive value is defined as follows: Number of patients with tumour progression or relapse / number of patients with interim 68Ga-PTF PET assessed as CXCR4-positive by central reviewer. The proportion obtained will be multiplied by 100 to obtain a percentage value.

The safety will be reported by frequency, system organ class categories, and severity of adverse events (AEs). The numbers and proportions of patients with any treatment-emergent adverse event (TEAE), and any serious TEAE will be summarized.

The negative predictive value (NPV) and the positive predictive value (PPV) for the prediction of PFS at the end of induction chemotherapy will be determined as described in outcome 1 and 2.

NPV of interim (after 6 ± 2 weeks of induction chemotherapy) 68Ga-PTF PET for the prediction of 16(±1) months CR.

PPV of interim (after 6 ± 2 weeks of induction chemotherapy) 68Ga-PTF PET for the prediction of 16(±1) months CR.

NPV of end-of-chemotherapy 68Ga-PTF PET for the prediction of 16(±1)-months CR.

PPV of end-of-chemotherapy 68Ga-PTF PET for the prediction of 16(±1)-months CR.

Response assessment will be performed 12 months after completion of induction chemotherapy and predictive values will be calculated with the results from the central visual analysis of the 68Ga-PTF PET scans at the different timepoints of induction chemotherapy.

Maximum standardized uptake value (SUVmax), SUVpeak and SUV mean will be determined for the pre-treatment 68Ga-PTF scan and will be analyzed for their association with 16(±1)-months PFS and also with 16(±1) months CR.

Maximum tumour-to background ratio (TBRmax) and TBRmean will be determined for the pre-treatment 68Ga-PTF scan and will be analyzed for their association with 16(±1)-months PFS and also with 16(±1) months CR.

Metabolic tumour volume (MTV) will be determined for the pre-treatment 68Ga-PTF scan by relative and fixed thresholding method and will be analyzed for their association with 16(±1)-months PFS and also with 16(±1) months CR.

Maximum standardized uptake value (SUVmax), SUVpeak and SUV mean will be determined for the interim 68Ga-PTF scan and will be analyzed for their association with 16(±1)-months PFS and also with 16(±1) months CR.

Maximum tumour-to background ratio (TBRmax) and TBRmean will be determined for the interim 68Ga-PTF scan and will be analyzed for their association with 16(±1)-months PFS and also with 16(±1) months CR.

Metabolic tumour volume (MTV) will be determined for the interim 68Ga-PTF scan by relative and fixed thresholding method and will be analyzed for their association with 16(±1)-months PFS and also with 16(±1) months CR.

The association of ΔSUVmax (change in SUVmax between pre-treatment 68Ga-PTF PET and interim 68Ga PTF PET) with 16(±1)-months PFS will be determined

In the fraction of patients from whom biopsy tissue is available, the sensitivity of the pre-treatment 68Ga-PTF PET to detect CXCR4 overexpression by immunohistochemistry (IHC) will be determined centrally on a patient basis

Diagnostic agreement between 68Ga-PTF PET and MRI at baseline imaging (after 6 +/-2 weeks of induction chemotherapy) will be determined on a patient level by evaluation of the concordance in the classification as CNSL-suspect ('yes'/'no') by 68Ga-PTF PET and MRI at baseline.

Diagnostic agreement between 68Ga-PTF PET and MRI at baseline imaging (after 6 +/-2 weeks of induction chemotherapy) will be determined on a patient level by comparing lesion numbers categorised as CNSL-suspect by 68Ga-PTF PET and MRI at baseline

The following will be calculated with respect to 68Ga-PTF-PET positivity:

1. Inter-reader agreement for pre-treatment 68Ga-PTF PET
2. Inter-reader agreement for interim 68Ga-PTF PET
3. Inter-reader agreement for 68Ga-PTF PET after induction chemotherapy completion
4. Intra-reader agreement for pre-treatment 68Ga-PTF PET
5. Intra-reader agreement for interim 68Ga-PTF PET
6. Intra-reader agreement for 68Ga-PTF PET after induction chemotherapy completion
7. Overall inter-reader agreement
8. Overall intra-reader agreement. The intra-reader assessment will be based on an appropriately sized sample of readings.

Spots Global Cancer Trial Database for [68Ga]Ga-PentixaFor PET Imaging in CNS Lymphoma Patients

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