LymphomaPhase 2RGDLymphomeNCT02490891
Study of the Angiogenesis by PET/CT in Patients With Lymphoma
A Phase 2 study testing RGD K5 PET scan in people with Lymphoma, run by Centre Henri Becquerel at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- RGD K5 PET scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 13 Nov 2015to 16 Oct 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Lymphoma
- Being tested
- RGD K5 PET scan
- Keywords
- Lymphoma, angiogenesis, PET scan
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RGD K5 PET scanDevice
PET scan with a tracer specific for angiogenesis (RGD K5) will be performed before and after 2 cycles of chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| PET scan with RGD K5 imaging | Experimental | PET scan with RGD K5 tracer will be performed before and after two cycles of chemotherapy Receives: Device: RGD K5 PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of angiogenesis with RGD K5 PET scan
Measure of fixation, metabolic volume and angiogenic volume with RGD K5 traver
Measured: 3 months
Secondary outcomes (3)
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.
Measured: 3 months
Overall survival
Time between inclusion and death whatever the cause
Measured: 18 months
Disease-free survival
Time between inclusion and progression or death
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2015 (estimated)
- Study start13 Nov 2015
- Primary completion14 Dec 2018
- Study completion16 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Henri Becquerel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Vera, MD, PhD, Principal investigator, Centre Henri Becquerel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490891
- Sponsor's protocol ID
- CHB14.02
- Acronym
- RGDLymphome
- Status last verified
- Dec 2025
- First submitted
- 1 Jul 2015
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Angiogenesis Measured by PET/CT With 18F-RGD-K5 in Patients With Lymphoma : a Preliminary Study
- ClinicalTrials.gov ID
- NCT02490891
- Acronym / sponsor ID
- RGDLymphome / CHB14.02
- Conditions
- Lymphoma
- Keywords
- Lymphoma, angiogenesis, PET scan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Centre Henri BecquerelUniversity, hospital or other
- Study start
- 13 Nov 2015 (actual)
- Primary completion
- 14 Dec 2018 (actual)
- Study completion
- 16 Oct 2020 (actual)
- First posted
- 7 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET scan with RGD K5 imaging | Experimental | Device: RGD K5 PET scanPET scan with RGD K5 tracer will be performed before and after two cycles of chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RGD K5 PET scanPET scan with a tracer specific for angiogenesis (RGD K5) will be performed before and after 2 cycles of chemotherapy | Device | PET scan with RGD K5 imaging |
Primary outcome
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 secondary outcomes
Measure of angiogenic volume with K5 tracer
Time frame: 3 months
Overall survival
Time frame: 18 months
Disease-free survival
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
Related trials for Lymphoma
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Not yet recruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Vera, MD, PhD principal investigator
Centre Henri Becquerel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RGD K5 PET scan in people with Lymphoma, run by Centre Henri Becquerel at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of angiogenesis with RGD K5 PET scan (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.