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Completed

NCT Number: NCT02490891

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

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

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Key information

Conditions

Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Henri Becquerel

Rouen, 76038, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

RGD K5 PET scan

Device

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

Primary outcomes

  1. Measure of angiogenesis with RGD K5 PET scan

    Time frame: 3 months

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

Secondary outcomes

  1. 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.

  2. Overall survival

    Time frame: 18 months

    Time between inclusion and death whatever the cause

  3. Disease-free survival

    Time frame: 18 months

    Time between inclusion and progression or death

Sponsors and collaborators

Lead sponsor

Centre Henri Becquerel

Other

Registry information

Official study title

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

Acronym: RGDLymphome

Important dates

Study start
2015
Primary completion
2018
Study completion
2020
First posted
Jul 7, 2015
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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