Study of the Angiogenesis by PET/CT in Patients With Lymphoma

Study Overview
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Brief Summary
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The aim of the study is to measure tumoral angiogenesis modifications by RGD-K5 PET/CT before and after 2 cycles of chemotherapy in patients with lymphoma and a large tumoral mass

Detailed Description
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After inclusion PET scans with FDG tracer and with a specific tracer of angiogenesis will be performed on patient with lymphoma. After two cycles of chemotherapy PET scans with the same tracers will be performed. Overall survival and disease free survival will be monitored during 18 months.

Official Title
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Study of the Angiogenesis Measured by PET/CT With 18F-RGD-K5 in Patients With Lymphoma : a Preliminary Study

Conditions
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Lymphoma

Intervention / Treatment
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* Device: RGD K5 PET scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female Age ≥ 18 years old OMS ≤ 1 Histological diagnosis of diffuse large B-cell lymphoma what ever the subtype Presence of measurable tumor with at least a node mass superior to 3 centimeters Stage I to IV Inform consent signed Exclusion Criteria: Primary cerebral lymphoma Absence of fixing on FDG-PET exam Pregnant , child bearing, breast feeding or without effective contraception method woman Hypersensitivity to RGD-K5 Hypersensitivity to FDG Poorly controlled diabètes (glycemia ≥ 10 millimoles/liter) Neoplastic disease (less than 2 years or in progression)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PET scan with RGD K5 imaging<br>PET scan with RGD K5 tracer will be performed before and after two cycles of chemotherapy | Device: RGD K5 PET scan<br>* PET scan with a tracer specific for angiogenesis (RGD K5) will be performed before and after 2 cycles of chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of angiogenesis with RGD K5 PET scan | Measure of fixation, metabolic volume and angiogenic volume with RGD K5 traver | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of angiogenic volume with K5 tracer | Measure of SUV max, SUV peak, SUV mean, metabolic volume and angiogenic volume to determine angiogenesis parameters with RGD-K5 PET scansand correlation with results of anatomopathology. | 3 months | 
| Overall survival | Time between inclusion and death whatever the cause | 18 months | 
| Disease-free survival | Time between inclusion and progression or death | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphoma, angiogenesis, PET scan