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

December 29, 2025 updated by: Centre Henri Becquerel

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rouen, France, 76038
        • Centre Henri Becquerel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PET scan with RGD K5 imaging
PET scan with RGD K5 tracer will be performed before and after two cycles of chemotherapy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of angiogenesis with RGD K5 PET scan
Time Frame: 3 months
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
Time Frame: 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.
3 months
Overall survival
Time Frame: 18 months
Time between inclusion and death whatever the cause
18 months
Disease-free survival
Time Frame: 18 months
Time between inclusion and progression or death
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Henri Becquerel

Investigators

  • Principal Investigator: Pierre Vera, MD, PhD, Centre Henri Becquerel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2015

Primary Completion (Actual)

December 14, 2018

Study Completion (Actual)

October 16, 2020

Study Registration Dates

First Submitted

July 1, 2015

First Submitted That Met QC Criteria

July 2, 2015

First Posted (Estimated)

July 7, 2015

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 29, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHB14.02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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