Breast CancerTRECAMNCT02101320
Hand-held Gamma Camera in the SNOLL Procedure
A study testing TRECAM in people with Breast Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
In France, breast cancer affects approximately 53,000 new cases per year. The investigators have to take care more and more women with subclinical lesions (nonpalpable), and it represents around 25% to 35% of the diagnosed breast cancers. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- TRECAM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- 20 May 2015to 19 Jun 2018
- Phase
- Interventional
- 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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years
- Patients undergoing SNOLL procedure for breast non palpable invasive cancer (ultrasound image target) confirmed by biopsy before surgery
- Clinical T0N0 stage
- Before the SNOLL procedure, patients will be informed on all this procedure
- A free and informed consent must be obtained
Who cannot join
- Multifocal breast cancer, diffuse microcalcifications
- Non-palpable breast cancer without ultrasound target
- Isolated in situ cancer or invasive cancer associated with extended in situ carcinoma
- Patients who underwent neoadjuvant chemotherapy
- Palpable axillary nodes on clinical examination or with a suspicious or positive cytology
- Pregnant patient
- History of axillary surgery or mammoplasty
- Allergy to any component of the tracking technique
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contribution of a Hand-held Gamma Camera (TreCam) to the SNOLL(Occult Breast Lesion Localization Plus Sentinel Node Biopsy) Procedure in Breast Cancer
In France, breast cancer affects approximately 53,000 new cases per year. The investigators have to take care more and more women with subclinical lesions (nonpalpable), and it represents around 25% to 35% of the diagnosed breast cancers. The main problem of the surgical management of these lesions is the quality of preoperative identification which determines the quality of surgery and oncological and cosmetic outcomes. For this type of lesion, SNOLL (Sentinel Node and Occult Lesion Localization) procedure could be proposed. This is a radioactive labeling of the tumor site and sentinel lymph node (SLN). The investigators want to evaluate the potential benefits of using a hand held camera called TreCam in this SNOLL procedure. This camera permits to obtain nuclear imaging at the bedside and in the operating theater.
Read the detailed description
Hypothesis:
The use of intraoperative TReCam improves the surgical procedure by providing relevant information during surgery to reduce the rate of further surgery for inappropriate margins.
Main Objective:
Evaluation of the contribution of TreCam in SNOLL procedure.
Main endpoint:
The rate of further surgery for inappropriate margins of the lumpectomy (less than 3mm)
Second endpoint:
Lumpectomy's characteristics, Cosmetics results Number of SLNs detected with TreCam at the different times of the procedure. Operative duration
Plan experimental :
Multicentric (3 centers) Phase II randomized non comparative study. All patients with non-palpable invasive cancer histologically proven and with ultrasound target will have SNOLL procedure.
Patients will be randomized preoperatively into two groups. Group 1: patients with a resection of the lesions according to the procedure SNOLL without the use of TReCam.
Group 2: patients with a resection of the lesions according to the procedure SNOLL with the use of TReCam.
In group 1:
- Day-1: Injection of Tc99m (Nanocis) in contact with the tumor under ultrasound guidance followed by a lymphoscintigraphy (LS): Localization and counting of the radioactive SLNs. Localization of the tumor site.
- Day 0: Before incision, exploration with the classic gamma probe (GP) for the localization of the different surgical areas (breast and axillary) is performed. Removal of SLN is achieved thanks to double detection (colorimetric and radioactive). After incision, radioactive SLN are identified by GP. At the end of the SLN procedure, the operator checks the absence of residual activity and controls with preoperative LS. In case of non detection of SLN or metastases identified during extemporaneous examination an axillary node dissection is performed. The GP is also used to guide lumpectomy and verify the absence of significant residual radioactivity after lumpectomy. Extemporaneous examination of lumpectomy specimen (size, limits of resection) is performed. Additional shaving of the cavity margins is appreciated by the surgeon.
In group 2 :
TReCam is used at different stages of SNOLL procedure:
- Day-1: A mapping with TReCam is performed after LS. (without LS results)
- Day 0: Before incision, in addition to GP, TReCam is used to define number and localization of SLN and the tumor site.
- At the end of the usual SLN procedure, axillary area is also explored by TReCam in order to find residual SLN.
- After lumpectomy, absence of significant residual radioactivity is checked by GP and TReCam
- Operative duration will be reported.
- Difficulties in data acquisition with TReCam.
- Collection of all the histological results.
- Outcome: Cosmetic results, decision of further surgery for inappropriate margins.
Total duration study: 13 months: Inclusion period : 12 months; Follow up : 1 month
Statistics
- Sample size. This is a phase II 2-steps randomized non comparative study. N= 30 patients in each group. This will allow to test the potential interest of TReCAm in group 2 using an optimal II-stage design based on the number of patients without reintervention (success). The tested hypothesis are: H0: p=p0 avec p0 = 80% (poor technique) H1: p=p1>p0 avec p1 = 95% (good technique) N= 30 patients per group will be considered, method proposed by R.P. A'Hern (Stat Med 2001 :20. 859-866). The required power was set at 80% and the alpha risk was set at 5%.
- Strategy analysis of data collected Populations studied: The primary analysis will focus on all randomized patients (intention to treat analysis). Given the type of patients and the evaluation time of the primary endpoint, it is unlikely that there is lost sight. However, any patient with no information available on the primary endpoint will be classified as having a reoperation.
- Justification of statistical tests
Descriptive analysis:
All quantitative parameters will be summarized descriptively in each group of treatment modality and for each time they are collected. The analysis will include descriptive statistics for each quantitative parameter each time: average, standard deviation, minimum, maximum, median and quartiles, number of missing values. Qualitative parameters are expressed by the frequency distribution and accurate bilateral confidence intervals to 95% associated. (asymptotic estimators will not be used because of the considered effective).
- Conditions
- Breast Cancer
- Being tested
- TRECAM
- Keywords
- surgery, nuclear medicine, Lymphoscintigraphy, Gamma Camera, SNOLL, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRECAMDevice
Also called hand held Camera
using the camera during the surgery
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | No intervention | Patients with a resection of the lesions according to the procedure SNOLL without the use of TReCam. |
| Group 2 | Experimental | Patients with a resection of the lesions according to the procedure SNOLL with the use of TReCam. Receives: Device: TRECAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of further surgery for non in sano or inadequate (less than 3 mm security margins) lumpectomy piece's margins.
Measured: Between 2 and 3 weeks
Secondary outcomes (11)
Size, volume and weight of the lumpectomy.
Measured: between 2 and 3 weeks
Status of resection margins
During surgery
Measured: one day
Cosmetics results: 4 point Score
EXCELLENT: the treated breast is almost identical to untreated breast GOOD: minor difference between the treated breast and untreated breast. FAIR: obvious difference between the treated breast and untreated breast. POOR: major aesthetic and functional sequelae in the treated breast.
Measured: between 2 and 3 weeks
Morbidity
(hematoma, abscess...).
Measured: between 2 and 3 weeks
Volume of resection / tumor volume
Volume of resection / tumor volume:
(Length x width x height) specimen / (π / 6) d3.(d is the histological maximum diameter of the lesion) Length x width x height) specimen / (π / 6) d3.(d is the histological maximum diameter of the lesion
Measured: between 2 and 3 weeks
Duration of utilization of TreCam at The day before surgery and before induction of anesthesia for the location of the breast injection site and SLN.
The day before surgery, and at the day of surgery
Measured: 2 days
Duration of utilization of TreCam at at the end of the SLN procedure for verifying the absence of radioactivity.
Day of surgery
Measured: One Day
Duration of utilization of TreCam at each step of the procedure during the breast exploration before lumpectomy.
Measured: One day before the surgery
Duration of utilization of TreCam at at the end of lumpectomy for acquisition of images of the tumor's bed after removal of the radioactive target and for acquisition of image of the lumpectomy's specimen.
Before surgery
Measured: One day
Difficulties in data acquisition Using a scale of 4 items : VERY EASY, EASY, DIFFICULT, IMPOSSIBLE
Measured: one day
Comparison between imaging data provided in preoperative time by TreCam and by standard LS: image's quality, location of the injection's site, location and number of SLN.
preoperative time
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study start20 May 2015
- Primary completion19 Jun 2018
- Study completion19 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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 Assistance Publique - Hôpitaux de ParisThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Responsible party
- Sponsor
- Investigators
- Alexandre BRICOU, MD, Principal investigator, Hôpital Jean Verdier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101320
- Sponsor's protocol ID
- P120704
- Acronym
- TRECAM
- Status last verified
- Jul 2019
- First submitted
- 6 Feb 2014
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Barranger E, Uzan S, Pitre S, Duval MA, Charon Y. [Development of a hand-held gamma camera (POCI) in the sentinel node biopsy for breast cancer]. Pathol Biol (Paris). 2008 Jul;56(5):254-6. doi: 10.1016/j.patbio.2007.09.009. Epub 2008 Feb 21. No abstract available. French.
PubMed 18178328Medina-Franco H, Abarca-Perez L, Garcia-Alvarez MN, Ulloa-Gomez JL, Romero-Trejo C, Sepulveda-Mendez J. Radioguided occult lesion localization (ROLL) versus wire-guided lumpectomy for non-palpable breast lesions: a randomized prospective evaluation. J Surg Oncol. 2008 Feb 1;97(2):108-11. doi: 10.1002/jso.20880.
PubMed 18181162Lavoue V, Nos C, Clough KB, Baghaie F, Zerbib E, Poulet B, Lefrere Belda MA, Ducellier A, Lecuru F. Simplified technique of radioguided occult lesion localization (ROLL) plus sentinel lymph node biopsy (SNOLL) in breast carcinoma. Ann Surg Oncol. 2008 Sep;15(9):2556-61. doi: 10.1245/s10434-008-9994-y. Epub 2008 Jun 24.
PubMed 18574635Monti S, Galimberti V, Trifiro G, De Cicco C, Peradze N, Brenelli F, Fernandez-Rodriguez J, Rotmensz N, Latronico A, Berrettini A, Mauri M, Machado L, Luini A, Paganelli G. Occult breast lesion localization plus sentinel node biopsy (SNOLL): experience with 959 patients at the European Institute of Oncology. Ann Surg Oncol. 2007 Oct;14(10):2928-31. doi: 10.1245/s10434-007-9452-2. Epub 2007 Aug 1.
PubMed 17674108Kerrou K, Pitre S, Coutant C, Rouzier R, Ancel PY, Lebeaux C, Huchet V, Montravers F, Pascal O, Duval MA, Lefebvre F, Menard L, Uzan S, Charon Y, Barranger E. The usefulness of a preoperative compact imager, a hand-held gamma-camera for breast cancer sentinel node biopsy: final results of a prospective double-blind, clinical study. J Nucl Med. 2011 Sep;52(9):1346-53. doi: 10.2967/jnumed.111.090464. Epub 2011 Aug 17.
PubMed 21849400Bricou A, Duval MA, Charon Y, Barranger E. Mobile gamma cameras in breast cancer care - a review. Eur J Surg Oncol. 2013 May;39(5):409-16. doi: 10.1016/j.ejso.2013.02.008. Epub 2013 Mar 7.
PubMed 23465183The Tumor Resection Camera (TReCam), a multipixel imaging probe for radio-guided surgery.E. Netter, L. Pinot, L. Ménard, M.-A. Duval, B. Janvier, F. Lefebvre, R. Siebert, Y. Charon. Nuclear Science Symposium Conference Record (NSS/MIC), 2009 IEEE, 2573-2576
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of a Hand-held Gamma Camera (TreCam) to the SNOLL(Occult Breast Lesion Localization Plus Sentinel Node Biopsy) Procedure in Breast Cancer
- ClinicalTrials.gov ID
- NCT02101320
- Acronym / sponsor ID
- TRECAM / P120704
- Conditions
- Breast Cancer
- Keywords
- surgery, nuclear medicine, Lymphoscintigraphy, Gamma Camera, SNOLL, breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Study start
- 20 May 2015 (actual)
- Primary completion
- 19 Jun 2018 (actual)
- Study completion
- 19 Jun 2018 (actual)
- First posted
- 2 Apr 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.
In France, breast cancer affects approximately 53,000 new cases per year. The investigators have to take care more and more women with subclinical lesions (nonpalpable), and it represents around 25% to 35% of the diagnosed breast cancers. The main problem of the surgical management of these lesions is the quality of preoperative identification which determines the quality of surgery and oncological and cosmetic outcomes. For this type of lesion, SNOLL (Sentinel Node and Occult Lesion Localization) procedure could be proposed. This is a radioactive labeling of the tumor site and sentinel lymph node (SLN). The investigators want to evaluate the potential benefits of using a hand held camera called TreCam in this SNOLL procedure. This camera permits to obtain nuclear imaging at the bedside and in the operating theater.
Detailed description
Hypothesis:
The use of intraoperative TReCam improves the surgical procedure by providing relevant information during surgery to reduce the rate of further surgery for inappropriate margins.
Main Objective:
Evaluation of the contribution of TreCam in SNOLL procedure.
Main endpoint:
The rate of further surgery for inappropriate margins of the lumpectomy (less than 3mm)
Second endpoint:
Lumpectomy's characteristics, Cosmetics results Number of SLNs detected with TreCam at the different times of the procedure. Operative duration
Plan experimental :
Multicentric (3 centers) Phase II randomized non comparative study. All patients with non-palpable invasive cancer histologically proven and with ultrasound target will have SNOLL procedure.
Patients will be randomized preoperatively into two groups. Group 1: patients with a resection of the lesions according to the procedure SNOLL without the use of TReCam.
Group 2: patients with a resection of the lesions according to the procedure SNOLL with the use of TReCam.
In group 1:
- Day-1: Injection of Tc99m (Nanocis) in contact with the tumor under ultrasound guidance followed by a lymphoscintigraphy (LS): Localization and counting of the radioactive SLNs. Localization of the tumor site.
- Day 0: Before incision, exploration with the classic gamma probe (GP) for the localization of the different surgical areas (breast and axillary) is performed. Removal of SLN is achieved thanks to double detection (colorimetric and radioactive). After incision, radioactive SLN are identified by GP. At the end of the SLN procedure, the operator checks the absence of residual activity and controls with preoperative LS. In case of non detection of SLN or metastases identified during extemporaneous examination an axillary node dissection is performed. The GP is also used to guide lumpectomy and verify the absence of significant residual radioactivity after lumpectomy. Extemporaneous examination of lumpectomy specimen (size, limits of resection) is performed. Additional shaving of the cavity margins is appreciated by the surgeon.
In group 2 :
TReCam is used at different stages of SNOLL procedure:
- Day-1: A mapping with TReCam is performed after LS. (without LS results)
- Day 0: Before incision, in addition to GP, TReCam is used to define number and localization of SLN and the tumor site.
- At the end of the usual SLN procedure, axillary area is also explored by TReCam in order to find residual SLN.
- After lumpectomy, absence of significant residual radioactivity is checked by GP and TReCam
- Operative duration will be reported.
- Difficulties in data acquisition with TReCam.
- Collection of all the histological results.
- Outcome: Cosmetic results, decision of further surgery for inappropriate margins.
Total duration study: 13 months: Inclusion period : 12 months; Follow up : 1 month
Statistics
- Sample size. This is a phase II 2-steps randomized non comparative study. N= 30 patients in each group. This will allow to test the potential interest of TReCAm in group 2 using an optimal II-stage design based on the number of patients without reintervention (success). The tested hypothesis are: H0: p=p0 avec p0 = 80% (poor technique) H1: p=p1>p0 avec p1 = 95% (good technique) N= 30 patients per group will be considered, method proposed by R.P. A'Hern (Stat Med 2001 :20. 859-866). The required power was set at 80% and the alpha risk was set at 5%.
- Strategy analysis of data collected Populations studied: The primary analysis will focus on all randomized patients (intention to treat analysis). Given the type of patients and the evaluation time of the primary endpoint, it is unlikely that there is lost sight. However, any patient with no information available on the primary endpoint will be classified as having a reoperation.
- Justification of statistical tests
Descriptive analysis:
All quantitative parameters will be summarized descriptively in each group of treatment modality and for each time they are collected. The analysis will include descriptive statistics for each quantitative parameter each time: average, standard deviation, minimum, maximum, median and quartiles, number of missing values. Qualitative parameters are expressed by the frequency distribution and accurate bilateral confidence intervals to 95% associated. (asymptotic estimators will not be used because of the considered effective).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | No intervention | –Patients with a resection of the lesions according to the procedure SNOLL without the use of TReCam. |
| Group 2 | Experimental | Device: TRECAMPatients with a resection of the lesions according to the procedure SNOLL with the use of TReCam. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients older than 18 years
- Patients undergoing SNOLL procedure for breast non palpable invasive cancer (ultrasound image target) confirmed by biopsy before surgery
- Clinical T0N0 stage
- Before the SNOLL procedure, patients will be informed on all this procedure
- A free and informed consent must be obtained
Key exclusion criteria (8 listed)
- Multifocal breast cancer, diffuse microcalcifications
- Non-palpable breast cancer without ultrasound target
- Isolated in situ cancer or invasive cancer associated with extended in situ carcinoma
- Patients who underwent neoadjuvant chemotherapy
- Palpable axillary nodes on clinical examination or with a suspicious or positive cytology
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 |
|---|---|---|
| TRECAMAlso: hand held Camerausing the camera during the surgery | Device | Group 2 |
Primary outcome
Rate of further surgery for non in sano or inadequate (less than 3 mm security margins) lumpectomy piece's margins.
Time frame: Between 2 and 3 weeks
11 secondary outcomes
Size, volume and weight of the lumpectomy.
Time frame: between 2 and 3 weeks
Status of resection margins
Time frame: one day
Cosmetics results: 4 point Score
Time frame: between 2 and 3 weeks
Morbidity
Time frame: between 2 and 3 weeks
Volume of resection / tumor volume
Time frame: between 2 and 3 weeks
Duration of utilization of TreCam at The day before surgery and before induction of anesthesia for the location of the breast injection site and SLN.
Time frame: 2 days
Duration of utilization of TreCam at at the end of the SLN procedure for verifying the absence of radioactivity.
Time frame: One Day
Duration of utilization of TreCam at each step of the procedure during the breast exploration before lumpectomy.
Time frame: One day before the surgery
Duration of utilization of TreCam at at the end of lumpectomy for acquisition of images of the tumor's bed after removal of the radioactive target and for acquisition of image of the lumpectomy's specimen.
Time frame: One day
Difficulties in data acquisition Using a scale of 4 items : VERY EASY, EASY, DIFFICULT, IMPOSSIBLE
Time frame: one day
Comparison between imaging data provided in preoperative time by TreCam and by standard LS: image's quality, location of the injection's site, location and number of SLN.
Time frame: One 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 31 Jul 2019.
- Background: PubMed 18178328Barranger E, Uzan S, Pitre S, Duval MA, Charon Y. [Development of a hand-held gamma camera (POCI) in the sentinel node biopsy for breast cancer]. Pathol Biol (Paris). 2008 Jul;56(5):254-6. doi: 10.1016/j.patbio.2007.09.009. Epub 2008 Feb 21. No abstract available. French.
- Background: PubMed 18181162Medina-Franco H, Abarca-Perez L, Garcia-Alvarez MN, Ulloa-Gomez JL, Romero-Trejo C, Sepulveda-Mendez J. Radioguided occult lesion localization (ROLL) versus wire-guided lumpectomy for non-palpable breast lesions: a randomized prospective evaluation. J Surg Oncol. 2008 Feb 1;97(2):108-11. doi: 10.1002/jso.20880.
- Background: PubMed 18574635Lavoue V, Nos C, Clough KB, Baghaie F, Zerbib E, Poulet B, Lefrere Belda MA, Ducellier A, Lecuru F. Simplified technique of radioguided occult lesion localization (ROLL) plus sentinel lymph node biopsy (SNOLL) in breast carcinoma. Ann Surg Oncol. 2008 Sep;15(9):2556-61. doi: 10.1245/s10434-008-9994-y. Epub 2008 Jun 24.
- Background: PubMed 17674108Monti S, Galimberti V, Trifiro G, De Cicco C, Peradze N, Brenelli F, Fernandez-Rodriguez J, Rotmensz N, Latronico A, Berrettini A, Mauri M, Machado L, Luini A, Paganelli G. Occult breast lesion localization plus sentinel node biopsy (SNOLL): experience with 959 patients at the European Institute of Oncology. Ann Surg Oncol. 2007 Oct;14(10):2928-31. doi: 10.1245/s10434-007-9452-2. Epub 2007 Aug 1.
- Background: PubMed 21849400Kerrou K, Pitre S, Coutant C, Rouzier R, Ancel PY, Lebeaux C, Huchet V, Montravers F, Pascal O, Duval MA, Lefebvre F, Menard L, Uzan S, Charon Y, Barranger E. The usefulness of a preoperative compact imager, a hand-held gamma-camera for breast cancer sentinel node biopsy: final results of a prospective double-blind, clinical study. J Nucl Med. 2011 Sep;52(9):1346-53. doi: 10.2967/jnumed.111.090464. Epub 2011 Aug 17.
- Background: PubMed 23465183Bricou A, Duval MA, Charon Y, Barranger E. Mobile gamma cameras in breast cancer care - a review. Eur J Surg Oncol. 2013 May;39(5):409-16. doi: 10.1016/j.ejso.2013.02.008. Epub 2013 Mar 7.
- BackgroundThe Tumor Resection Camera (TReCam), a multipixel imaging probe for radio-guided surgery.E. Netter, L. Pinot, L. Ménard, M.-A. Duval, B. Janvier, F. Lefebvre, R. Siebert, Y. Charon. Nuclear Science Symposium Conference Record (NSS/MIC), 2009 IEEE, 2573-2576
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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.
Alexandre BRICOU, MD principal investigator
Hôpital Jean Verdier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRECAM in people with Breast Cancer, run by Assistance Publique - Hôpitaux de Paris 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 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 31 Jul 2019. 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.
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?
Rate of further surgery for non in sano or inadequate (less than 3 mm security margins) lumpectomy piece's margins. (time frame: Between 2 and 3 weeks). 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 NCT02101320, which also lists 7 linked publications.
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 31 Jul 2019.