Breast CancerNCT05708664
Precision Breast Conserving Surgery With Guidance.
A study testing precision breast conserving surgery guided by wire guided localization combined with MDCT guided 3D reconstruction in people with Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
From 2021 to 2022, 31 patients with unifocal breast cancer were enrolled for precision breast conserving surgery (PBCS) guided by wire guided localization (WGL) combined with CT guided 3D reconstruction. Surrounded WGL was performed under local anesthesia, followed by an immediate contrast enhanced CT scan. 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?
- precision breast conserving surgery guided by wire guided localization combined with MDCT guided 3D reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to 1 Jan 2023
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women with T1/T2 invasive breast cancer confirmed by core biopsy
- be suitable for BCS
- the tumor should be unilateral and unifocal which is clearly visible with US
Who cannot join
- patients with an extensive intraductal component in invasive cancer
- patients who were pregnant or breast-feeding
- patients receiving neoadjuvant therapies.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210000
About this study
Official title: Precision Breast Conserving Surgery With the Guidance of Localization Combined With Multidetector CT 3-dimensional Image Reconstruction: a Single Center, Prospective, Cohort Study.
From 2021 to 2022, 31 patients with unifocal breast cancer were enrolled for precision breast conserving surgery (PBCS) guided by wire guided localization (WGL) combined with CT guided 3D reconstruction. Surrounded WGL was performed under local anesthesia, followed by an immediate contrast enhanced CT scan. PBCS guided by CT guided 3D reconstruction was performed one day after the localization. Women who underwent palpation guided breast conserving surgery (BCS) were included as control. Two-sided Student t test, Fisher's exact test and chi-square test was applied.
Read the detailed description
Background Breast conserving surgery (BCS) with radiation is accepted as a standard local treatment for early-stage breast cancer. This is largely based on the results of NSABP B-06 trial， demonstrating no significant difference in survival among patients who received total mastectomy or lumpectomy [1]. More recent studies showed that the overall survival was superior for BCS compared with mastectomy [2,3,4]. Furthermore, long-term quality of life (QoL) was better in patients treated with BCS than with mastectomy [5]. Advantages in survival and QoL have led to a higher demand for BCS.
Success of BCS is characterized by negative margins and a good cosmetic outcome. This requires doctors to precisely remove the tumor while preserving as much normal tissue as possible. Current guidelines strongly recommend achieving "no ink on tumor" for invasive breast cancer (IBC) . More widely clear margins do not significantly decrease the rate of ipsilateral breast cancer recurrence (IBCR) [6]. However, conventional localization techniques only provide approximate tumor center and fail to provide tumor extents [7]. In clinical practice, doctors may remove more tissue to achieve negative margins and avoid a reoperative intervention. Among the patients treating with BCS, 30% survivals were dissatisfied with the cosmetic outcome [8].
Wire-guided localization (WGL) is a feasible, widely used technology used for the localization of nonpalpable breast lesions prior to surgical management. The flexible self-retaining wire can be inserted into the exact lesion guided by ultrasound (US) or mammography. The surgeon than uses the wire as a guide to excise the lesion [9]. At the same time, the metal needle is visible under CT. The role of multidetector CT (MDCT) is limited in the diagnosis of breast tumors [10,11]. However, MDCT has many unique advantages. First of all, patients are in the supine position during MDCT scan, which is consistent with the surgical position. Secondly, MDCT is effective for the detection of tumor extension [12]. Beside, MDCT is convenient for 3-dimensional (3D) reconstruction. MDCT guided 3D reconstruction has been widely used in clinic, including surgery guidance. Therefore, we speculate that WGL combined with MDCT can be helpful for precision breast conserving surgery (PBCS).
The aims of this cohort study were to determine whether WGL combined with MDCT guided 3D reconstruction could guide PBCS, and to access the cosmetic outcome reported by patients.
Study Design We did a single center, prospective, cohort study in one group of our department from August 2021 to June 2022. The treatment for all patients were discussed by the multi-disciplinary team in our center. The decision in this study was decided by shared decision-making between patients and multi-disciplinary teams. All procedures for the enrolled patients were performed by one surgeon. All CT images were processed by an experienced radiologist. All specimens were evaluated by two experienced pathologists.
The study was conducted with the approval of the institutional ethics committee of The First Affiliated Hospital with Nanjing Medical University (2021-SR-226) and complied with the Declaration of Helsinki. Informed consent was obtained from all patients.
Pathologic Evaluation Pathologists performed intraoperative frozen section analysis. The size of the breast specimen was measured, and the specimen was sliced sequentially into 5mm sections. Then, the length of the margins and the size of the tumor were measured with both the naked eye and microscope. Ink on tumor was defined as a positive margin. When a positive margin was encountered, the surgeon decided to perform an additional incision or a total mastectomy. After the surgery, hematoxylin eosin stain was also performed to confirm the intraoperative analysis and the final report was subject to hematoxylin eosin stain. All pathological examinations were performed by two pathologists with more than 10 years of experience in breast pathologic examination independently.
Patient reported outcomes (PROs) Breast Cancer Treatment Outcome Scale (BCTOS) cosmetic subscale was used to access patient reported cosmetic outcomes in our study [19]. The cosmetic subscale of BCTOS contains 8 items (showing in Supplementary Table 1) designed to assess womens'subjective evaluations of cosmetic outcomes of breast cancer treatment. Each item is rated on a scale of 1 to 4 by the patient, with 1 indicated no difference compared with the untreated breast, 2 slight, 3 moderate, and 4 a large difference. The score was derived from the mean of the answers for each item, with higher scores indicating more adverse effects. Participants completed the scale at baseline (before surgery), 1 month post operation and 6 months post radiotherapy (RT). The scores were statistically analyzed to show the cosmetic changes reported by patients.
Statistical Analysis Quantitive data were reported as the mean with standard deviation. The sample size was calculated as 31 in the PBCS group. The baseline characteristics in the two groups were well balanced. So, the differences between the two groups were analyzed with the chi-square test or Fisher's exact test for categorical variables and the Student t test for continuous variables. All P values were two-sided with 5% significance levels. All analyses were performed using the software STATA version 11.0 (Computer Resource Center, America).
- Conditions
- Breast Cancer
- Being tested
- precision breast conserving surgery guided by wire guided localization combined with MDCT guided 3D reconstruction
- Keywords
- breast cancer, precision breast conserving surgery, wire-guided localization, 3-dimensional image reconstruction
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
precision breast conserving surgery guided by wire guided localization combined with MDCT guided 3D reconstructionProcedure or surgery
Local anesthesia was induced by using 1% lidocaine before wire location. The wire (localization set, PAJUNK) was placed in the superior, inferior, lateral and interior edge of the tumor through a 20-gauge needle using US guidance one day before BCS, respectively. Then, the patient underwent an immediate supine contrast enhanced CT (Philips Brilliance iCT) scan of the breast. The radiologist performed 3D reconstruction of CT images prior to surgery. Finally, the surgical procedures were performed by experienced breast surgeons combing 3D reconstruction of CT images and wire localizations one day after the localization.
| Study group | Role | What they receive |
|---|---|---|
| PBCS | Experimental | patients enrolled in the PBCS group underwent precision breast conserving surgery guided by wire guided localization combined with MDCT guided 3D reconstruction. Receives: Procedure: precision breast conserving surgery guided by wire guided localization combined with MDCT guided 3D reconstruction |
| Control | No intervention | patients enrolled in the Control group underwent palpation guided breast conserving surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sum of located margin resection widths
The sum of the resection widths of located superior, inferior, lateral and interior margins
Measured: 1 month post operation
Secondary outcomes (4)
The specimen diameter
The diameter of the breast specimen was measured by pathologists
Measured: 1 month post operation
the largest margin resection width
the largest resection width of the located superior, inferior, lateral and interior margins
Measured: 1 month post operation
Operation time
the duration of the surgery
Measured: intraoperative
Patients reported outcomes
Breast Cancer Treatment Outcome Scale (BCTOS) cosmetic subscale was used to access patient reported cosmetic outcomes in our study.
Measured: participants completed the scale at baseline (before surgery), 1 month post operation and 6 months post radiotherapy (RT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start1 Aug 2021
- Primary completion30 Jun 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui Xie, Doctor, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708664
- Sponsor's protocol ID
- PBCST
- Status last verified
- Jan 2023
- First submitted
- 9 Jan 2023
- Last updated
- 1 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41. doi: 10.1056/NEJMoa022152.
PubMed 12393820Wrubel E, Natwick R, Wright GP. Breast-Conserving Therapy is Associated with Improved Survival Compared with Mastectomy for Early-Stage Breast Cancer: A Propensity Score Matched Comparison Using the National Cancer Database. Ann Surg Oncol. 2021 Feb;28(2):914-919. doi: 10.1245/s10434-020-08829-4. Epub 2020 Jul 13.
PubMed 32661849Kim H, Lee SB, Nam SJ, Lee ES, Park BW, Park HY, Lee HJ, Kim J, Chung Y, Kim HJ, Ko BS, Lee JW, Son BH, Ahn SH. Survival of Breast-Conserving Surgery Plus Radiotherapy versus Total Mastectomy in Early Breast Cancer. Ann Surg Oncol. 2021 Sep;28(9):5039-5047. doi: 10.1245/s10434-021-09591-x. Epub 2021 Jan 25.
PubMed 33492542Li P, Li L, Xiu B, Zhang L, Yang B, Chi Y, Xue J, Wu J. The Prognoses of Young Women With Breast Cancer (</=35 years) With Different Surgical Options: A Propensity Score Matching Retrospective Cohort Study. Front Oncol. 2022 Feb 28;12:795023. doi: 10.3389/fonc.2022.795023. eCollection 2022.
PubMed 35296009Hanson SE, Lei X, Roubaud MS, DeSnyder SM, Caudle AS, Shaitelman SF, Hoffman KE, Smith GL, Jagsi R, Peterson SK, Smith BD. Long-term Quality of Life in Patients With Breast Cancer After Breast Conservation vs Mastectomy and Reconstruction. JAMA Surg. 2022 Jun 1;157(6):e220631. doi: 10.1001/jamasurg.2022.0631. Epub 2022 Jun 8.
PubMed 35416926Moran MS, Schnitt SJ, Giuliano AE, Harris JR, Khan SA, Horton J, Klimberg S, Chavez-MacGregor M, Freedman G, Houssami N, Johnson PL, Morrow M; Society of Surgical Oncology; American Society for Radiation Oncology. Society of Surgical Oncology-American Society for Radiation Oncology consensus guideline on margins for breast-conserving surgery with whole-breast irradiation in stages I and II invasive breast cancer. J Clin Oncol. 2014 May 10;32(14):1507-15. doi: 10.1200/JCO.2013.53.3935. Epub 2014 Feb 10.
PubMed 24516019Leiloglou M, Kedrzycki MS, Elson DS, Leff DR. ASO Author Reflections: Towards Fluorescence Guided Tumor Identification for Precision Breast Conserving Surgery. Ann Surg Oncol. 2022 Dec;29(Suppl 3):564-565. doi: 10.1245/s10434-021-10626-6. Epub 2021 Aug 18. No abstract available.
PubMed 34406539Hill-Kayser CE, Vachani C, Hampshire MK, Di Lullo GA, Metz JM. Cosmetic outcomes and complications reported by patients having undergone breast-conserving treatment. Int J Radiat Oncol Biol Phys. 2012 Jul 1;83(3):839-44. doi: 10.1016/j.ijrobp.2011.08.013. Epub 2011 Dec 2.
PubMed 22137022Ahmed M, Rubio IT, Klaase JM, Douek M. Surgical treatment of nonpalpable primary invasive and in situ breast cancer. Nat Rev Clin Oncol. 2015 Nov;12(11):645-63. doi: 10.1038/nrclinonc.2015.161. Epub 2015 Sep 29.
PubMed 26416152O'Connell AM, Karellas A, Vedantham S, Kawakyu-O'Connor DT. Newer Technologies in Breast Cancer Imaging: Dedicated Cone-Beam Breast Computed Tomography. Semin Ultrasound CT MR. 2018 Feb;39(1):106-113. doi: 10.1053/j.sult.2017.09.001. Epub 2017 Sep 5.
PubMed 29317032He Z, Chen Z, Tan M, Elingarami S, Liu Y, Li T, Deng Y, He N, Li S, Fu J, Li W. A review on methods for diagnosis of breast cancer cells and tissues. Cell Prolif. 2020 Jul;53(7):e12822. doi: 10.1111/cpr.12822. Epub 2020 Jun 12.
PubMed 32530560Doihara H, Fujita T, Takabatake D, Takahashi H, Ogasawara Y, Shimizu N. Clinical significance of multidetector-row computed tomography in breast surgery. Breast J. 2006 Sep-Oct;12(5 Suppl 2):S204-9. doi: 10.1111/j.1075-122X.2006.00323.x.
PubMed 16959003
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Breast Conserving Surgery With the Guidance of Localization Combined With Multidetector CT 3-dimensional Image Reconstruction: a Single Center, Prospective, Cohort Study.
- ClinicalTrials.gov ID
- NCT05708664
- Acronym / sponsor ID
- PBCST
- Conditions
- Breast Cancer
- Keywords
- breast cancer, precision breast conserving surgery, wire-guided localization, 3-dimensional image reconstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 1 Feb 2023 (actual)
- 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.
From 2021 to 2022, 31 patients with unifocal breast cancer were enrolled for precision breast conserving surgery (PBCS) guided by wire guided localization (WGL) combined with CT guided 3D reconstruction. Surrounded WGL was performed under local anesthesia, followed by an immediate contrast enhanced CT scan. PBCS guided by CT guided 3D reconstruction was performed one day after the localization. Women who underwent palpation guided breast conserving surgery (BCS) were included as control. Two-sided Student t test, Fisher's exact test and chi-square test was applied.
Detailed description
Background Breast conserving surgery (BCS) with radiation is accepted as a standard local treatment for early-stage breast cancer. This is largely based on the results of NSABP B-06 trial， demonstrating no significant difference in survival among patients who received total mastectomy or lumpectomy [1]. More recent studies showed that the overall survival was superior for BCS compared with mastectomy [2,3,4]. Furthermore, long-term quality of life (QoL) was better in patients treated with BCS than with mastectomy [5]. Advantages in survival and QoL have led to a higher demand for BCS.
Success of BCS is characterized by negative margins and a good cosmetic outcome. This requires doctors to precisely remove the tumor while preserving as much normal tissue as possible. Current guidelines strongly recommend achieving "no ink on tumor" for invasive breast cancer (IBC) . More widely clear margins do not significantly decrease the rate of ipsilateral breast cancer recurrence (IBCR) [6]. However, conventional localization techniques only provide approximate tumor center and fail to provide tumor extents [7]. In clinical practice, doctors may remove more tissue to achieve negative margins and avoid a reoperative intervention. Among the patients treating with BCS, 30% survivals were dissatisfied with the cosmetic outcome [8].
Wire-guided localization (WGL) is a feasible, widely used technology used for the localization of nonpalpable breast lesions prior to surgical management. The flexible self-retaining wire can be inserted into the exact lesion guided by ultrasound (US) or mammography. The surgeon than uses the wire as a guide to excise the lesion [9]. At the same time, the metal needle is visible under CT. The role of multidetector CT (MDCT) is limited in the diagnosis of breast tumors [10,11]. However, MDCT has many unique advantages. First of all, patients are in the supine position during MDCT scan, which is consistent with the surgical position. Secondly, MDCT is effective for the detection of tumor extension [12]. Beside, MDCT is convenient for 3-dimensional (3D) reconstruction. MDCT guided 3D reconstruction has been widely used in clinic, including surgery guidance. Therefore, we speculate that WGL combined with MDCT can be helpful for precision breast conserving surgery (PBCS).
The aims of this cohort study were to determine whether WGL combined with MDCT guided 3D reconstruction could guide PBCS, and to access the cosmetic outcome reported by patients.
Study Design We did a single center, prospective, cohort study in one group of our department from August 2021 to June 2022. The treatment for all patients were discussed by the multi-disciplinary team in our center. The decision in this study was decided by shared decision-making between patients and multi-disciplinary teams. All procedures for the enrolled patients were performed by one surgeon. All CT images were processed by an experienced radiologist. All specimens were evaluated by two experienced pathologists.
The study was conducted with the approval of the institutional ethics committee of The First Affiliated Hospital with Nanjing Medical University (2021-SR-226) and complied with the Declaration of Helsinki. Informed consent was obtained from all patients.
Pathologic Evaluation Pathologists performed intraoperative frozen section analysis. The size of the breast specimen was measured, and the specimen was sliced sequentially into 5mm sections. Then, the length of the margins and the size of the tumor were measured with both the naked eye and microscope. Ink on tumor was defined as a positive margin. When a positive margin was encountered, the surgeon decided to perform an additional incision or a total mastectomy. After the surgery, hematoxylin eosin stain was also performed to confirm the intraoperative analysis and the final report was subject to hematoxylin eosin stain. All pathological examinations were performed by two pathologists with more than 10 years of experience in breast pathologic examination independently.
Patient reported outcomes (PROs) Breast Cancer Treatment Outcome Scale (BCTOS) cosmetic subscale was used to access patient reported cosmetic outcomes in our study [19]. The cosmetic subscale of BCTOS contains 8 items (showing in Supplementary Table 1) designed to assess womens'subjective evaluations of cosmetic outcomes of breast cancer treatment. Each item is rated on a scale of 1 to 4 by the patient, with 1 indicated no difference compared with the untreated breast, 2 slight, 3 moderate, and 4 a large difference. The score was derived from the mean of the answers for each item, with higher scores indicating more adverse effects. Participants completed the scale at baseline (before surgery), 1 month post operation and 6 months post radiotherapy (RT). The scores were statistically analyzed to show the cosmetic changes reported by patients.
Statistical Analysis Quantitive data were reported as the mean with standard deviation. The sample size was calculated as 31 in the PBCS group. The baseline characteristics in the two groups were well balanced. So, the differences between the two groups were analyzed with the chi-square test or Fisher's exact test for categorical variables and the Student t test for continuous variables. All P values were two-sided with 5% significance levels. All analyses were performed using the software STATA version 11.0 (Computer Resource Center, America).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PBCS | Experimental | Procedure: precision breast conserving surgery guided by wire guided localization combined with MDCT guided 3D reconstructionpatients enrolled in the PBCS group underwent precision breast conserving surgery guided by wire guided localization combined with MDCT guided 3D reconstruction. |
| Control | No intervention | –patients enrolled in the Control group underwent palpation guided breast conserving surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- women with T1/T2 invasive breast cancer confirmed by core biopsy
- be suitable for BCS
- the tumor should be unilateral and unifocal which is clearly visible with US
Key exclusion criteria (3 listed)
- patients with an extensive intraductal component in invasive cancer
- patients who were pregnant or breast-feeding
- patients receiving neoadjuvant therapies.
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 |
|---|---|---|
| precision breast conserving surgery guided by wire guided localization combined with MDCT guided 3D reconstructionLocal anesthesia was induced by using 1% lidocaine before wire location. The wire (localization set, PAJUNK) was placed in the superior, inferior, lateral and interior edge of the tumor through a 20-gauge needle using US guidance one day before BCS, respectively. Then, the patient underwent an immediate supine contrast enhanced CT (Philips Brilliance iCT) scan of the breast. The radiologist performed 3D reconstruction of CT images prior to surgery. Finally, the surgical procedures were performed by experienced breast surgeons combing 3D reconstruction of CT images and wire localizations one day after the localization. | Procedure or surgery | PBCS |
Primary outcome
The sum of located margin resection widths
Time frame: 1 month post operation
The sum of the resection widths of located superior, inferior, lateral and interior margins
4 secondary outcomes
The specimen diameter
Time frame: 1 month post operation
the largest margin resection width
Time frame: 1 month post operation
Operation time
Time frame: intraoperative
Patients reported outcomes
Time frame: participants completed the scale at baseline (before surgery), 1 month post operation and 6 months post radiotherapy (RT)
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 1 Feb 2023.
- Background: PubMed 12393820Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41. doi: 10.1056/NEJMoa022152.
- Background: PubMed 32661849Wrubel E, Natwick R, Wright GP. Breast-Conserving Therapy is Associated with Improved Survival Compared with Mastectomy for Early-Stage Breast Cancer: A Propensity Score Matched Comparison Using the National Cancer Database. Ann Surg Oncol. 2021 Feb;28(2):914-919. doi: 10.1245/s10434-020-08829-4. Epub 2020 Jul 13.
- Background: PubMed 33492542Kim H, Lee SB, Nam SJ, Lee ES, Park BW, Park HY, Lee HJ, Kim J, Chung Y, Kim HJ, Ko BS, Lee JW, Son BH, Ahn SH. Survival of Breast-Conserving Surgery Plus Radiotherapy versus Total Mastectomy in Early Breast Cancer. Ann Surg Oncol. 2021 Sep;28(9):5039-5047. doi: 10.1245/s10434-021-09591-x. Epub 2021 Jan 25.
- Background: PubMed 35296009Li P, Li L, Xiu B, Zhang L, Yang B, Chi Y, Xue J, Wu J. The Prognoses of Young Women With Breast Cancer (</=35 years) With Different Surgical Options: A Propensity Score Matching Retrospective Cohort Study. Front Oncol. 2022 Feb 28;12:795023. doi: 10.3389/fonc.2022.795023. eCollection 2022.
- Background: PubMed 35416926Hanson SE, Lei X, Roubaud MS, DeSnyder SM, Caudle AS, Shaitelman SF, Hoffman KE, Smith GL, Jagsi R, Peterson SK, Smith BD. Long-term Quality of Life in Patients With Breast Cancer After Breast Conservation vs Mastectomy and Reconstruction. JAMA Surg. 2022 Jun 1;157(6):e220631. doi: 10.1001/jamasurg.2022.0631. Epub 2022 Jun 8.
- Background: PubMed 24516019Moran MS, Schnitt SJ, Giuliano AE, Harris JR, Khan SA, Horton J, Klimberg S, Chavez-MacGregor M, Freedman G, Houssami N, Johnson PL, Morrow M; Society of Surgical Oncology; American Society for Radiation Oncology. Society of Surgical Oncology-American Society for Radiation Oncology consensus guideline on margins for breast-conserving surgery with whole-breast irradiation in stages I and II invasive breast cancer. J Clin Oncol. 2014 May 10;32(14):1507-15. doi: 10.1200/JCO.2013.53.3935. Epub 2014 Feb 10.
- Background: PubMed 34406539Leiloglou M, Kedrzycki MS, Elson DS, Leff DR. ASO Author Reflections: Towards Fluorescence Guided Tumor Identification for Precision Breast Conserving Surgery. Ann Surg Oncol. 2022 Dec;29(Suppl 3):564-565. doi: 10.1245/s10434-021-10626-6. Epub 2021 Aug 18. No abstract available.
- Background: PubMed 22137022Hill-Kayser CE, Vachani C, Hampshire MK, Di Lullo GA, Metz JM. Cosmetic outcomes and complications reported by patients having undergone breast-conserving treatment. Int J Radiat Oncol Biol Phys. 2012 Jul 1;83(3):839-44. doi: 10.1016/j.ijrobp.2011.08.013. Epub 2011 Dec 2.
- Background: PubMed 26416152Ahmed M, Rubio IT, Klaase JM, Douek M. Surgical treatment of nonpalpable primary invasive and in situ breast cancer. Nat Rev Clin Oncol. 2015 Nov;12(11):645-63. doi: 10.1038/nrclinonc.2015.161. Epub 2015 Sep 29.
- Background: PubMed 29317032O'Connell AM, Karellas A, Vedantham S, Kawakyu-O'Connor DT. Newer Technologies in Breast Cancer Imaging: Dedicated Cone-Beam Breast Computed Tomography. Semin Ultrasound CT MR. 2018 Feb;39(1):106-113. doi: 10.1053/j.sult.2017.09.001. Epub 2017 Sep 5.
- Background: PubMed 32530560He Z, Chen Z, Tan M, Elingarami S, Liu Y, Li T, Deng Y, He N, Li S, Fu J, Li W. A review on methods for diagnosis of breast cancer cells and tissues. Cell Prolif. 2020 Jul;53(7):e12822. doi: 10.1111/cpr.12822. Epub 2020 Jun 12.
- Background: PubMed 16959003Doihara H, Fujita T, Takabatake D, Takahashi H, Ogasawara Y, Shimizu N. Clinical significance of multidetector-row computed tomography in breast surgery. Breast J. 2006 Sep-Oct;12(5 Suppl 2):S204-9. doi: 10.1111/j.1075-122X.2006.00323.x.
Related trials for Breast Cancer
Active, not recruitingPhase 2
Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating Patients With Locally Advanced or Inflammatory Triple Negative Breast Cancer
Inflammatory Breast Cancer, Stage IIA Breast Cancer
RecruitingObservational study
Cancer Experience Registry (CER) for Cancer Patients and Caregivers
Neoplasms, Cancer
RecruitingPhase 1/2
Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers
Pancreatic Cancer, Renal Cell Cancer
Active, not recruiting
Interest of Broadband Spectroscopy Analysis by Infrared Laser on Liquid Biopsies in Breast Cancer Screening
Breast Cancer Female, BRCA1 Mutation
Recruiting
Safe De-escalation of Chemotherapy for Stage 1 Breast Cancer
Breast Cancer
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.
Hui Xie, Doctor principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing precision breast conserving surgery guided by wire guided localization combined with MDCT guided 3D reconstruction in people with Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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 3 inclusion and 3 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 1 Feb 2023. 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 China. 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?
The sum of located margin resection widths (time frame: 1 month post operation). 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 NCT05708664, which also lists 12 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 1 Feb 2023; AzTrials last refreshed its copy on 30 Oct 2026.