Back to resultsStudy of the Angiogenesis by PET/CT in Patients With Lymphoma (RGDLymphome)
Primary Purpose
Lymphoma
Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
RGD K5 PET scan
Sponsored by
About this trial
This is an interventional other trial for Lymphoma focused on measuring Lymphoma, angiogenesis, PET scan
Eligibility Criteria
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)
Sites / Locations
- Centre Henri BecquerelRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PET scan with RGD K5 imaging
Arm Description
PET scan with RGD K5 tracer will be performed before and after two cycles of chemotherapy
Outcomes
Primary Outcome Measures
Measure of angiogenesis with RGD K5 PET scan
Measure of fixation, metabolic volume and angiogenic volume with RGD K5 traver
Secondary Outcome Measures
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.
Overall survival
Time between inclusion and death whatever the cause
Disease-free survival
Time between inclusion and progression or death
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02490891
Brief Title
Study of the Angiogenesis by PET/CT in Patients With Lymphoma
Acronym
RGDLymphome
Official Title
Study of the Angiogenesis Measured by PET/CT With 18F-RGD-K5 in Patients With Lymphoma : a Preliminary Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (Actual)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
May 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Henri Becquerel
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
Lymphoma, angiogenesis, PET scan
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PET scan with RGD K5 imaging
Arm Type
Experimental
Arm Description
PET scan with RGD K5 tracer will be performed before and after two cycles of chemotherapy
Intervention Type
Device
Intervention Name(s)
RGD K5 PET scan
Intervention Description
PET scan with a tracer specific for angiogenesis (RGD K5) will be performed before and after 2 cycles of chemotherapy
Primary Outcome Measure Information:
Title
Measure of angiogenesis with RGD K5 PET scan
Description
Measure of fixation, metabolic volume and angiogenic volume with RGD K5 traver
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Measure of angiogenic volume with K5 tracer
Description
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.
Time Frame
3 months
Title
Overall survival
Description
Time between inclusion and death whatever the cause
Time Frame
18 months
Title
Disease-free survival
Description
Time between inclusion and progression or death
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre Vera, MD, PhD
Phone
+33232082278
Email
pierre.vera@chb.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Doriane Richard, PhD
Phone
+33232082985
Email
doriane.richard@chb.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Vera, MD, PhD
Organizational Affiliation
Centre Henri Becquerel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Vera, MD,PhD
Phone
+33232082255
Email
pierre.vera@chb.unicancer.fr
12. IPD Sharing Statement
Learn more about this trial
Study of the Angiogenesis by PET/CT in Patients With Lymphoma
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