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

Phase 2

• Conditions: Lymphoma
• Interventions: Device: RGD K5 PET scan

• Registration Number: NCT02490891
• Lead Sponsor: Centre Henri Becquerel

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-07-01
• Study First Submitted QC: 2015-07-02
• Study First Posted: 2015-07-07
• Study Start: 2015-11
• Status Verified: 2017-07
• Last Update Submitted: 2018-07-10
• Last Update Posted: 2018-07-11
• Primary Completion: 2018-11
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET scan with RGD K5 imaging	RGD K5 PET scan	PET scan with RGD K5 tracer will be performed before and after two cycles of chemotherapy

Primary Outcome Measures

Name	Time	Method
Measure of angiogenesis with RGD K5 PET scan	3 months	Measure of fixation, metabolic volume and angiogenic volume with RGD K5 traver

Secondary Outcome Measures

Name	Time	Method
Measure of angiogenic volume with K5 tracer	3 months	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.
Overall survival	18 months	Time between inclusion and death whatever the cause
Disease-free survival	18 months	Time between inclusion and progression or death

Trial Locations

Locations (1)

Centre Henri Becquerel; 🇫🇷 Rouen, France