Untreated B-Chronic Lymphocytic Leukemia or Diffuse Large B Cells Lymphoma PatientsPhase 1FLUDATEPNCT02128945
Dosimetry and Biodistribution of [18F]-Fludarabine in Lymphoid Malignancies
A Phase 1 study testing [18F] - Fludarabine PET/CT in people with Untreated B-Chronic Lymphocytic Leukemia or Diffuse Large B Cells Lymphoma Patients, run by University Hospital, Caen at 1 site in France.
Trial summary
The application of positron emission tomography with lymphoproliferative diseases today provides diagnostic and therapeutic information of major importance , especially in terms of speed and quality of response to treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Untreated B-Chronic Lymphocytic Leukemia or Diffuse Large B Cells Lymphoma Patients
- What is being tested?
- [18F] - Fludarabine PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to May 2016
- Phase
- Phase 1
- 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
- Adult over 18
- Signed written informed consent
- Untreated stage B or C chronic lymphocytic leukemia
- Untreated diffuse large B-cell lymphoma
- Eligible for PET-CT
- The subject must be covered by a social security system
Who cannot join
- Age under 18
- Patients concurrently included in an investigational trial
- Weight over 120 kg
- pregnant women
- active infectious disease
- immune hemolytic anemia
- patients with creatinine clearance < 30 ml/mn
- corticosteroid therapy
Trial locations and contacts
1 site in 1 country.
About this study
The application of positron emission tomography with lymphoproliferative diseases today provides diagnostic and therapeutic information of major importance , especially in terms of speed and quality of response to treatment. The radiopharmaceutical used in clinical practice for this exam is fluorodeoxyglucose 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose ([18F]-FDG) . However , the uptake of this tracer is not elective in lymphoid tissues , with a lack of specificity. In addition , the avidity of this tracer is unequal according to the histological subtype (lack of sensitivity).
To try to improve the results of this clinical exploration of lymphoid malignancies, the investigators developed a new radiopharmaceutical ( [18F] - fludarabine ). The idea of transforming the fludarabine radiopharmaceutical is based on the existence of a fluorine atom in the molecule and the pharmacokinetic characteristics of this drug. The [18F]-Fludarabine is a new radiopharmaceutical reproducing the same dosage formulation of fludarabine , a drug used for the treatment of certain types of lymphoproliferative diseases, especially those where the tumor cells have a low proliferation kinetics . This drug is used in therapy in particular pharmacokinetic effect for a high affinity for the lymphoid tissue . Preclinical results on normal and lymphoma xenograft -bearing mice showed a specificity restricted to lymphoid tissue fixation with [18F]-Fludarabine compared with [18F]-FDG .
Based on these encouraging results , the investigators propose in this work to explore the Dosimetry and Biodistribution of [18F] - Fludarabine in human lymphoproliferative diseases : 1)A first group of patients with non-Hodgkin's large cell lymphomas in which it already has a wealth of experience in exploration [18F]-FDG, and 2) a second group of patients with chronic lymphocytic leukemia, where the results of the exploration [18F]-FDG are considered disappointing and did not, for this reason, experienced clinical development.
- Being tested
- [18F] - Fludarabine PET/CT
- Keywords
- PET, Chronic lymphocytic Leukemia (CLL), Diffuse Large B Cells Lymphoma (DLBCL), Fludarabine
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F] - Fludarabine PET/CTOther
[18F] - Fludarabine PET/CT before treatment
| Study group | Role | What they receive |
|---|---|---|
| FLUDATEP | Experimental | [18F] - Fludarabine PET/CT Receives: Other: [18F] - Fludarabine PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized measure of [18F]-Fludarabine uptake in tumor tissue.
Measure of the Standard Uptake Value (SUV) for each lesion.
Measured: Day 0 ([18F]-Fludarabine PET-CT day)
Secondary outcomes (1)
Calculation of the equivalent dose to all organs and evaluation of effective dose to the whole body
Measured: Day 0 ([18F]-Fludarabine PET-CT day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Untreated B-Chronic Lymphocytic Leukemia or Diffuse Large B Cells Lymphoma PatientsStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- CNRS, UMR ISTCT 6301, LDM-TEP Groupe, GIP Cyceron, Caen, France
- Responsible party
- Sponsor
- Investigators
- Sylvain P CHANTEPIE, MD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128945
- Sponsor's protocol ID
- 2013-002796-18
- Other IDs
- 13-090
- Acronym
- FLUDATEP
- Status last verified
- Jan 2016
- First submitted
- 9 Apr 2014
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chantepie S, Hovhannisyan N, Guillouet S, Pelage JP, Ibazizene M, Bodet-Milin C, Carlier T, Gac AC, Reboursiere E, Vilque JP, Kraeber-Bodere F, Manrique A, Damaj G, Leporrier M, Barre L. 18F-Fludarabine PET for Lymphoma Imaging: First-in-Humans Study on DLBCL and CLL Patients. J Nucl Med. 2018 Sep;59(9):1380-1385. doi: 10.2967/jnumed.117.206920. Epub 2018 Feb 1.
PubMed 29419478
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dosimetry and Biodistribution of [18F]-Fludarabine in Lymphoid Malignancies
- ClinicalTrials.gov ID
- NCT02128945
- Acronym / sponsor ID
- FLUDATEP / 2013-002796-18
- Keywords
- PET, Chronic lymphocytic Leukemia (CLL), Diffuse Large B Cells Lymphoma (DLBCL), Fludarabine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- CNRS, UMR ISTCT 6301, LDM-TEP Groupe, GIP Cyceron, Caen, France
- Study start
- Apr 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 1 May 2014 (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 application of positron emission tomography with lymphoproliferative diseases today provides diagnostic and therapeutic information of major importance , especially in terms of speed and quality of response to treatment. The radiopharmaceutical used in clinical practice for this exam is fluorodeoxyglucose 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose ([18F]-FDG) . However , the uptake of this tracer is not elective in lymphoid tissues , with a lack of specificity. In addition , the avidity of this tracer is unequal according to the histological subtype (lack of sensitivity).
To try to improve the results of this clinical exploration of lymphoid malignancies, the investigators developed a new radiopharmaceutical ( [18F] - fludarabine ). The idea of transforming the fludarabine radiopharmaceutical is based on the existence of a fluorine atom in the molecule and the pharmacokinetic characteristics of this drug. The [18F]-Fludarabine is a new radiopharmaceutical reproducing the same dosage formulation of fludarabine , a drug used for the treatment of certain types of lymphoproliferative diseases, especially those where the tumor cells have a low proliferation kinetics . This drug is used in therapy in particular pharmacokinetic effect for a high affinity for the lymphoid tissue . Preclinical results on normal and lymphoma xenograft -bearing mice showed a specificity restricted to lymphoid tissue fixation with [18F]-Fludarabine compared with [18F]-FDG .
Based on these encouraging results , the investigators propose in this work to explore the Dosimetry and Biodistribution of [18F] - Fludarabine in human lymphoproliferative diseases : 1)A first group of patients with non-Hodgkin's large cell lymphomas in which it already has a wealth of experience in exploration [18F]-FDG, and 2) a second group of patients with chronic lymphocytic leukemia, where the results of the exploration [18F]-FDG are considered disappointing and did not, for this reason, experienced clinical development.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FLUDATEP | Experimental | Other: [18F] - Fludarabine PET/CT[18F] - Fludarabine PET/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult over 18
- Signed written informed consent
- Untreated stage B or C chronic lymphocytic leukemia
- Untreated diffuse large B-cell lymphoma
- Eligible for PET-CT
Key exclusion criteria (8 listed)
- Age under 18
- Patients concurrently included in an investigational trial
- Weight over 120 kg
- pregnant women
- active infectious disease
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 |
|---|---|---|
| [18F] - Fludarabine PET/CT[18F] - Fludarabine PET/CT before treatment | Other | FLUDATEP |
Primary outcome
Standardized measure of [18F]-Fludarabine uptake in tumor tissue.
Time frame: Day 0 ([18F]-Fludarabine PET-CT day)
Measure of the Standard Uptake Value (SUV) for each lesion.
1 secondary outcome
Calculation of the equivalent dose to all organs and evaluation of effective dose to the whole body
Time frame: Day 0 ([18F]-Fludarabine PET-CT day)
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 Apr 2026.
- Results publication: PubMed 29419478Chantepie S, Hovhannisyan N, Guillouet S, Pelage JP, Ibazizene M, Bodet-Milin C, Carlier T, Gac AC, Reboursiere E, Vilque JP, Kraeber-Bodere F, Manrique A, Damaj G, Leporrier M, Barre L. 18F-Fludarabine PET for Lymphoma Imaging: First-in-Humans Study on DLBCL and CLL Patients. J Nucl Med. 2018 Sep;59(9):1380-1385. doi: 10.2967/jnumed.117.206920. Epub 2018 Feb 1.
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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.
Sylvain P CHANTEPIE, MD principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [18F] - Fludarabine PET/CT in people with Untreated B-Chronic Lymphocytic Leukemia or Diffuse Large B Cells Lymphoma Patients, run by University Hospital, Caen 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 6 inclusion and 8 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 Apr 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Standardized measure of [18F]-Fludarabine uptake in tumor tissue. (time frame: Day 0 ([18F]-Fludarabine PET-CT day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02128945, which also lists 1 linked publication.
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 Apr 2026.