Breast CancerPhase 4CHIMTEPNCT00904410
Early Assessment of the Response to Neo-adjuvant Chemotherapy in Breast Cancer Patients With FDG-PET
A Phase 4 study testing FDG-PET in people with Breast Cancer, run by Centre Oscar Lambret at 1 site in France.
Trial summary
18F-FDG PET, a whole-body imaging technology based on glucose metabolism, can effectively detect subclinical and clinical therapeutic responses at stages that are earlier than those detected by conventional approaches. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- FDG-PET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- May 2005to 3 Dec 2010
- Phase
- Phase 4
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18
- Breast cancer treated by neo-adjuvant chemotherapy (T>2cm)
- Measurable lesions ,assessed clinically and by ultrasound
- Delay minimum between biopsy and PET: 15 days
- PS-WHO: 0
Who cannot join
- T<2cm
- Inflammatory breast cancer (T4d)
- Diabetic patients unbalanced (glycemia>1.40)
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
18F-FDG PET, a whole-body imaging technology based on glucose metabolism, can effectively detect subclinical and clinical therapeutic responses at stages that are earlier than those detected by conventional approaches.
We propose to conduct a prospective study to evaluate early therapeutic response using 18F-FDG PET before and after the 1st cycle of neo-adjuvant chemotherapy for breast cancer patients.
Variation of 18F-FDG PET uptake is compared to clinical and echographical tumor response evaluated after 3 cycles of chemotherapy.
The purpose is to estimate the capacity of 18F-FDG PET to differentiate responder and non-responder patients.
Read the detailed description
Further study details as provided by Centre Oscar Lambret
- Conditions
- Breast Cancer
- Being tested
- FDG-PET
- Keywords
- adenocarcinoma, breast
- Medical subject headings
- Breast Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG-PETOther
370 MBq of FDG one hour before imaging acquisition PET just before neo-adjuvant chemotherapy and just before the second cycle
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Other: FDG-PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation rate of SUV(BSA max)before and after the 1st cycle of neoadjuvant chemotherapy
Measured: before and 3 weeks after 1st cycle
Secondary outcomes (1)
Comparison to clinical and ultrasound assessment after the 3rd cycle of chemotherapy
Measured: 3 weeks after the 3rd cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2009 (estimated)
- Study startMay 2005
- Primary completionDec 2007
- Study completion3 Dec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- GAUTHIER Helene, Study chair, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00904410
- Sponsor's protocol ID
- CHIMTEPd-0402
- Other IDs
- 2005-003358-90, 2005
- Acronym
- CHIMTEP
- Status last verified
- Sep 2026
- First submitted
- 15 Mar 2007
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Assessment of the Response to Neo-adjuvant Chemotherapy in Breast Cancer Patients With FDG-PET
- ClinicalTrials.gov ID
- NCT00904410
- Acronym / sponsor ID
- CHIMTEP / CHIMTEPd-0402
- Conditions
- Breast Cancer
- Keywords
- adenocarcinoma, breast
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- May 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- 3 Dec 2010 (actual)
- First posted
- 19 May 2009 (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.
18F-FDG PET, a whole-body imaging technology based on glucose metabolism, can effectively detect subclinical and clinical therapeutic responses at stages that are earlier than those detected by conventional approaches.
We propose to conduct a prospective study to evaluate early therapeutic response using 18F-FDG PET before and after the 1st cycle of neo-adjuvant chemotherapy for breast cancer patients.
Variation of 18F-FDG PET uptake is compared to clinical and echographical tumor response evaluated after 3 cycles of chemotherapy.
The purpose is to estimate the capacity of 18F-FDG PET to differentiate responder and non-responder patients.
Detailed description
Further study details as provided by Centre Oscar Lambret
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: FDG-PET |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18
- Breast cancer treated by neo-adjuvant chemotherapy (T>2cm)
- Measurable lesions ,assessed clinically and by ultrasound
- Delay minimum between biopsy and PET: 15 days
- PS-WHO: 0
Key exclusion criteria (4 listed)
- T<2cm
- Inflammatory breast cancer (T4d)
- Diabetic patients unbalanced (glycemia>1.40)
- Pregnant or lactating women
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 |
|---|---|---|
| FDG-PET370 MBq of FDG one hour before imaging acquisition PET just before neo-adjuvant chemotherapy and just before the second cycle | Other | 1 |
Primary outcome
Variation rate of SUV(BSA max)before and after the 1st cycle of neoadjuvant chemotherapy
Time frame: before and 3 weeks after 1st cycle
1 secondary outcome
Comparison to clinical and ultrasound assessment after the 3rd cycle of chemotherapy
Time frame: 3 weeks after the 3rd cycle
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 17 Sep 2026.
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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.
GAUTHIER Helene study chair
Centre Oscar Lambret
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing FDG-PET in people with Breast Cancer, run by Centre Oscar Lambret 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 5 inclusion and 4 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 17 Sep 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Variation rate of SUV(BSA max)before and after the 1st cycle of neoadjuvant chemotherapy (time frame: before and 3 weeks after 1st cycle). 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 17 Sep 2026.