NCT02490891

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_2 lymphoma

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

November 13, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2018

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2020

Completed
Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

3.1 years

First QC Date

July 1, 2015

Last Update Submit

December 29, 2025

Conditions

Lymphoma

Keywords

Lymphoma, angiogenesis, PET scan

Outcome Measures

Primary Outcomes (1)

  • Measure of angiogenesis with RGD K5 PET scan

    Measure of fixation, metabolic volume and angiogenic volume with RGD K5 traver

    3 months

Secondary Outcomes (3)

  • Measure of angiogenic volume with K5 tracer

    3 months

  • Overall survival

    18 months

  • Disease-free survival

    18 months

Study Arms (1)

PET scan with RGD K5 imaging

EXPERIMENTAL

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

Device: RGD K5 PET scan

Interventions

RGD K5 PET scanDEVICE

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

PET scan with RGD K5 imaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Henri Becquerel

Rouen, 76038, France

Location

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Pierre Vera, MD, PhD

    Centre Henri Becquerel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2015

First Posted

July 7, 2015

Study Start

November 13, 2015

Primary Completion

December 14, 2018

Study Completion

October 16, 2020

Last Updated

January 2, 2026

Record last verified: 2025-12

Locations

FR(1)