Breast CancerPhase 3NCT00757302
Intraoperative Gamma Camera for Breast Cancer Surgery
A Phase 3 study testing SLN procedure (CarolIReS camera) in people with Breast Cancer and Ductal Carcinoma in Situ, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Aim: This study aims at evaluating the performances of an intraoperative gamma camera (field of view 10X10 cm), named CarolIReS, to detect axillary drainage and to assess the removal of sentinel lymph nodes (SLN) in breast surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Ductal Carcinoma in Situ
- What is being tested?
- SLN procedure (CarolIReS camera)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2008to Sep 2014
- Phase
- Phase 3
- 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
- Patient major at the time of breast surgery.
- Patient affiliated with a social security.
- Consent dated and signed by the investigator and the subject.
- Subject having been informed of the sentinel lymph node procedure during the visit prior to breast surgery.
- Patient having a unifocal infiltrative breast cancer (less than 2 cm) diagnosed preoperatively by core biopsy or cytology.
- Patient having a ductal carcinoma in situ (DCIS), diagnosed preoperatively by core biopsy or cytology.
Who cannot join
- Refusal of the patient to be included in the study.
- Pregnant patient or during breastfeeding.
- None of the patients will have undergone chemotherapy, locoregional radiotherapy or prevalent axillary lymph node.
- Diagnosed safeguarding justice and trust.
- Patient with a psychiatric disorder makes it impossible for the collection of informed consent-patient with tumors greater than 2 cm or multifocal.
- Prevalent axillary lymph node.
Trial locations and contacts
1 site in 1 country.
France1 site
CHRU, Hôpital Civil ,Service de Gynécologie-obstétrique
Strasbourg, 67091
About this study
Official title: Evaluation of a New Intraoperative Gamma Camera for the Sentinel Lymph Node Procedure in Breast Cancer
Aim: This study aims at evaluating the performances of an intraoperative gamma camera (field of view 10X10 cm), named CarolIReS, to detect axillary drainage and to assess the removal of sentinel lymph nodes (SLN) in breast surgery. Patients and Methods: SLN biopsy will be performed on 110 patients and the CarolIReS camera will be used preoperatively to localize SLNs. During surgery, individual removal of SLNs will be performed using a gamma probe named CarolIReS and their activity will be measured with a gamma ray counter. At the end of surgery, the CarolIReS camera will be used again to check the quality of surgery which will be followed by a surgical excision in case of remaining SLNs. Objectives: The main objective of this study is to evaluate the performances of the CarolIReS camera in assessing the axillary drainage of breast tumors and the surgical removal of SLNs. In addition, the possible correlation between the activity, the size, and the metastatic involvement of the SLNs will also be studied.Study hypothesis: Intraoperative cameras could be used to improve the efficiency of the SLN procedure
Read the detailed description
Group I : The SLN procedure will be initiated 18 hours before surgery using a preoperative injection of colloidal rhenium sulphur and technetium (0.4 ml, 20 MBq of Nanocis®; CIS Bio International, France) at the four cardinal points in the subareolar area. Lymphoscintigraphy will be obtained 3 hours after the injection. Immediately before surgery, the axillary drainage will be checked using the CarolIReS camera (FOV 10x10 cm²). During surgery, the search for radioactive nodes will be performed using the CarolIReS probe. In order to evaluate the CarolIReS camera sensitivity, the activity of the removed SLNs will be measured immediately after their resection by a gamma ray counter and they will then be submitted to pathological analysis with frozen section.
Group II : The SLN procedure will be initiated 18 hours before surgery using a preoperative injection of colloidal rhenium sulphur and technetium (0.4 ml, 20 MBq of Nanocis®; CIS Bio International, France) at the four cardinal points in the subareolar area. Lymphoscintigraphy will be obtained 3 hours after the injection. Immediately before surgery, the axillary drainage will be checked using the CarolIReS camera (FOV 10x10 cm²). During surgery, the search for radioactive nodes will be performed using the CarolIReS probe. In order to evaluate the CarolIReS camera sensitivity, the activity of the removed SLNs will be measured immediately after their resection by a gamma ray counter and they will then be submitted to pathological analysis with frozen section. After SLN removal and during the pathological analysis, the axillary area will once again be checked using the CarolIReS camera (followed by a further surgical excision in the case of remaining SLNs).
When the pathological analysis will diagnose a metastatic SLN, complete axillary lymph node dissection (ALND) will immediately be performed. In the case of negative SLN, serial sections and detection of cytokeratine (AE1/AE3; Dako, Zymed, CA, USA) will be performed during standard pathological analysis. Macrometastases will be defined as clusters of cancer cells ≥2 mm, micrometastases as clusters of cancer cells ≥0.2 mm and <2 mm, and isolated cancer cells as clusters of cancer cells <0.2 mm. ALND will be performed in cases of macro- or micrometastases.
- Conditions
- Breast Cancer, Ductal Carcinoma in Situ
- Being tested
- SLN procedure (CarolIReS camera)
- Keywords
- breast cancer, CarolIReS, intraoperative gamma camera, lymphoscintigraphy, sentinel lymph node, Hundred and ten patients with infiltrative breast cancer or ductal carcinoma in situ (DCIS), diagnosed preoperatively by core biopsy or cytology.
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLN procedure (CarolIReS camera)Device
Also called gamma camera carolires in detection on sentinel lymph node
Group I : The SLN procedure will be initiated 18 hours before surgery using a preoperative injection of colloidal rhenium sulphur and technetium (0.4 ml, 20 MBq of Nanocis®; CIS Bio International, France) at the four cardinal points in the subareolar area. Lymphoscintigraphy will be obtained 3 hours after the injection. Immediately before surgery, the axillary drainage will be checked using the CarolIReS camera (FOV 10x10 cm²).
Group II : The SLN procedure will be initiated 18 hours before surgery using a preoperative injection of colloidal rhenium sulphur and technetium (0.4 ml, 20 MBq of Nanocis®; CIS Bio International, France) at the four cardinal points in the subareolar area. Lymphoscintigraphy will be obtained 3 hours after the injection. Immediately before surgery, the axillary drainage will be checked using the CarolIReS camera (FOV 10x10 cm²).
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | For the first 10 patients, only a pre-operative procedure will be performed. Receives: Device: SLN procedure (CarolIReS camera) |
| II | Experimental | The last 100 patients will receive the complete procedure. Receives: Device: SLN procedure (CarolIReS camera) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects for which the gamma camera can detect sentinel lymph nodes (SLN) not identified by other technic.
Measured: 1 year
Secondary outcomes (2)
Proportion of subjects with at least one additional sentinel lymph nodes (SLN) detected by preoperative pictures with gamma camera.
Measured: 1 year
Proportion of subjects with at least one additional sentinel lymph nodes (SLN) detected by the pictures with gamma camera to intervene.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2013
- Study completionSep 2014
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 Breast CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Pluridisciplinaire Hubert Curien. UMR 7178 - CNRS/IN2P3, ULP. F-67037 Strasbourg, National Cancer Institute, France
- Responsible party
- Sponsor
- Investigators
- MATHELIN Carole, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00757302
- Sponsor's protocol ID
- 4126
- Status last verified
- Dec 2025
- First submitted
- 22 Sep 2008
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Mathelin C, Salvador S, Bekaert V, Croce S, Andriamisandratsoa N, Liegeois P, Prados E, Guyonnet JL, Grucker D, Brasse D. A new intraoperative gamma camera for the sentinel lymph node procedure in breast cancer. Anticancer Res. 2008 Sep-Oct;28(5B):2859-64.
PubMed 19031925
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Intraoperative Gamma Camera for the Sentinel Lymph Node Procedure in Breast Cancer
- ClinicalTrials.gov ID
- NCT00757302
- Acronym / sponsor ID
- 4126
- Conditions
- Breast Cancer, Ductal Carcinoma in Situ
- Keywords
- breast cancer, CarolIReS, intraoperative gamma camera, lymphoscintigraphy, sentinel lymph node, Hundred and ten patients with infiltrative breast cancer or ductal carcinoma in situ (DCIS), diagnosed preoperatively by core biopsy or cytology.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Collaborators
- Institut Pluridisciplinaire Hubert Curien. UMR 7178 - CNRS/IN2P3, ULP. F-67037 Strasbourg, National Cancer Institute, France
- Study start
- Sep 2008
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 23 Sep 2008 (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.
Aim: This study aims at evaluating the performances of an intraoperative gamma camera (field of view 10X10 cm), named CarolIReS, to detect axillary drainage and to assess the removal of sentinel lymph nodes (SLN) in breast surgery. Patients and Methods: SLN biopsy will be performed on 110 patients and the CarolIReS camera will be used preoperatively to localize SLNs. During surgery, individual removal of SLNs will be performed using a gamma probe named CarolIReS and their activity will be measured with a gamma ray counter. At the end of surgery, the CarolIReS camera will be used again to check the quality of surgery which will be followed by a surgical excision in case of remaining SLNs. Objectives: The main objective of this study is to evaluate the performances of the CarolIReS camera in assessing the axillary drainage of breast tumors and the surgical removal of SLNs. In addition, the possible correlation between the activity, the size, and the metastatic involvement of the SLNs will also be studied.Study hypothesis: Intraoperative cameras could be used to improve the efficiency of the SLN procedure
Detailed description
Group I : The SLN procedure will be initiated 18 hours before surgery using a preoperative injection of colloidal rhenium sulphur and technetium (0.4 ml, 20 MBq of Nanocis®; CIS Bio International, France) at the four cardinal points in the subareolar area. Lymphoscintigraphy will be obtained 3 hours after the injection. Immediately before surgery, the axillary drainage will be checked using the CarolIReS camera (FOV 10x10 cm²). During surgery, the search for radioactive nodes will be performed using the CarolIReS probe. In order to evaluate the CarolIReS camera sensitivity, the activity of the removed SLNs will be measured immediately after their resection by a gamma ray counter and they will then be submitted to pathological analysis with frozen section.
Group II : The SLN procedure will be initiated 18 hours before surgery using a preoperative injection of colloidal rhenium sulphur and technetium (0.4 ml, 20 MBq of Nanocis®; CIS Bio International, France) at the four cardinal points in the subareolar area. Lymphoscintigraphy will be obtained 3 hours after the injection. Immediately before surgery, the axillary drainage will be checked using the CarolIReS camera (FOV 10x10 cm²). During surgery, the search for radioactive nodes will be performed using the CarolIReS probe. In order to evaluate the CarolIReS camera sensitivity, the activity of the removed SLNs will be measured immediately after their resection by a gamma ray counter and they will then be submitted to pathological analysis with frozen section. After SLN removal and during the pathological analysis, the axillary area will once again be checked using the CarolIReS camera (followed by a further surgical excision in the case of remaining SLNs).
When the pathological analysis will diagnose a metastatic SLN, complete axillary lymph node dissection (ALND) will immediately be performed. In the case of negative SLN, serial sections and detection of cytokeratine (AE1/AE3; Dako, Zymed, CA, USA) will be performed during standard pathological analysis. Macrometastases will be defined as clusters of cancer cells ≥2 mm, micrometastases as clusters of cancer cells ≥0.2 mm and <2 mm, and isolated cancer cells as clusters of cancer cells <0.2 mm. ALND will be performed in cases of macro- or micrometastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Device: SLN procedure (CarolIReS camera)For the first 10 patients, only a pre-operative procedure will be performed. |
| II | Experimental | Device: SLN procedure (CarolIReS camera)The last 100 patients will receive the complete procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient major at the time of breast surgery.
- Patient affiliated with a social security.
- Consent dated and signed by the investigator and the subject.
- Subject having been informed of the sentinel lymph node procedure during the visit prior to breast surgery.
- Patient having a unifocal infiltrative breast cancer (less than 2 cm) diagnosed preoperatively by core biopsy or cytology.
Key exclusion criteria (6 listed)
- Refusal of the patient to be included in the study.
- Pregnant patient or during breastfeeding.
- None of the patients will have undergone chemotherapy, locoregional radiotherapy or prevalent axillary lymph node.
- Diagnosed safeguarding justice and trust.
- Patient with a psychiatric disorder makes it impossible for the collection of informed consent-patient with tumors greater than 2 cm or multifocal.
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 |
|---|---|---|
| SLN procedure (CarolIReS camera)Also: gamma camera carolires in detection on sentinel lymph nodeGroup I : The SLN procedure will be initiated 18 hours before surgery using a preoperative injection of colloidal rhenium sulphur and technetium (0.4 ml, 20 MBq of Nanocis®; CIS Bio International, France) at the four cardinal points in the subareolar area. Lymphoscintigraphy will be obtained 3 hours after the injection. Immediately before surgery, the axillary drainage will be checked using the CarolIReS camera (FOV 10x10 cm²). Group II : The SLN procedure will be initiated 18 hours before surgery using a preoperative injection of colloidal rhenium sulphur and technetium (0.4 ml, 20 MBq of Nanocis®; CIS Bio International, France) at the four cardinal points in the subareolar area. Lymphoscintigraphy will be obtained 3 hours after the injection. Immediately before surgery, the axillary drainage will be checked using the CarolIReS camera (FOV 10x10 cm²). | Device | I, II |
Primary outcome
Proportion of subjects for which the gamma camera can detect sentinel lymph nodes (SLN) not identified by other technic.
Time frame: 1 year
2 secondary outcomes
Proportion of subjects with at least one additional sentinel lymph nodes (SLN) detected by preoperative pictures with gamma camera.
Time frame: 1 year
Proportion of subjects with at least one additional sentinel lymph nodes (SLN) detected by the pictures with gamma camera to intervene.
Time frame: 1 year
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 22 Dec 2025.
- Results publication: PubMed 19031925Mathelin C, Salvador S, Bekaert V, Croce S, Andriamisandratsoa N, Liegeois P, Prados E, Guyonnet JL, Grucker D, Brasse D. A new intraoperative gamma camera for the sentinel lymph node procedure in breast cancer. Anticancer Res. 2008 Sep-Oct;28(5B):2859-64.
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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.
MATHELIN Carole, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SLN procedure (CarolIReS camera) in people with Breast Cancer and Ductal Carcinoma in Situ, run by University Hospital, Strasbourg, France 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 6 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 22 Dec 2025. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Proportion of subjects for which the gamma camera can detect sentinel lymph nodes (SLN) not identified by other technic. (time frame: 1 year). 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 NCT00757302, 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 22 Dec 2025.