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

Lymphoma Clinical Trial

— RGDLymphome  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02490891
• Other study ID #: CHB14.02
• Status: Recruiting
• Phase: Phase 2
• Start date: November 2015
• Est. completion date: May 2020

Study information

• Verified date: July 2017
• Source: Centre Henri Becquerel
• Contact: Pierre Vera, MD, PhD
• Phone: +33232082278
• Email: pierre.vera[@]chb.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: May 2020
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Lymphoma

Intervention

Device:
• RGD K5 PET scan
PET scan with a tracer specific for angiogenesis (RGD K5) will be performed before and after 2 cycles of chemotherapy

Locations

Country	Name	City	State
France	Centre Henri Becquerel	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Henri Becquerel

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of angiogenesis with RGD K5 PET scan	Measure of fixation, metabolic volume and angiogenic volume with RGD K5 traver	3 months
Secondary	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
Secondary	Overall survival	Time between inclusion and death whatever the cause	18 months
Secondary	Disease-free survival	Time between inclusion and progression or death	18 months