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

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ClinicalTrials.gov Identifier: NCT02490891
Recruitment Status : Unknown
Verified July 2017 by Centre Henri Becquerel.
Recruitment status was:  Recruiting
First Posted : July 7, 2015
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Henri Becquerel

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

Condition or disease Intervention/treatment Phase
Lymphoma Device: RGD K5 PET scan Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Study of the Angiogenesis Measured by PET/CT With 18F-RGD-K5 in Patients With Lymphoma : a Preliminary Study
Actual Study Start Date : November 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02490891


Contacts
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Contact: Pierre Vera, MD, PhD +33232082278 pierre.vera@chb.unicancer.fr
Contact: Doriane Richard, PhD +33232082985 doriane.richard@chb.unicancer.fr

Locations
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France
Centre Henri Becquerel Recruiting
Rouen, France, 76038
Contact: Pierre Vera, MD,PhD    +33232082255    pierre.vera@chb.unicancer.fr   
Sponsors and Collaborators
Centre Henri Becquerel
Investigators
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Principal Investigator: Pierre Vera, MD, PhD Centre Henri Becquerel
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Responsible Party: Centre Henri Becquerel
ClinicalTrials.gov Identifier: NCT02490891    
Other Study ID Numbers: CHB14.02
First Posted: July 7, 2015    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2017
Keywords provided by Centre Henri Becquerel:
Lymphoma, angiogenesis, PET scan
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases