An observational study in Breast Cancer, sponsored by BTG International Inc.. Completed at 6 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-10.
Sponsored by BTG International Inc. · Observational
This prospective, observational study will evaluate the patient-based sentinel lymph node detection rate when using the Infracyanine® (indocyanine green) dye technique in patients undergoing surgery for breast cancer.
The study will describe the demographic, clinical, and tumour characteristics of patients with breast cancer undergoing surgery.
The study will describe the characteristics of how the indocyanine green dye technique is used including the dose and volume of dye used, the number and type of injection sites used to give the dye, the equipment used to detect the dye and locate the sentinel lymph node, and whether indocyanine green is used on its own or with other dyes (blue dye and/or 99mTechnetium dye).
The study will evaluate the characteristics of sentinel lymph node biopsy procedures performed using indocyanine green dye including the number of biopsies performed, the time taken to detect the sentinel lymph node and perform the biopsy, and how many sentinel lymph nodes are detected using indocyanine green dye, blue dye, and 99mTechnetium dye.
The study will also assess the safety of using indocyanine green dye for 6 weeks following surgery.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 101 is below the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →BTG International Inc. is the lead sponsor of 12 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study will be conducted at French hospitals involved in the management of female patients with breast cancer where indocyanine green is used in routine practice. Patients will be enrolled from approximately 5 sites in metropolitan France.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intervention description: Intraoperative identification of sentinel lymph node
Intervention description: indocyanine green (5 to 10 mg \[ie, 2 to 4 mL of a 2.5 mg/mL solution\]) administered by periareolar or peritumoural route
1%), 2-5 mL administered by periareolar or peritumoural route
(99mTc, 0.2 - 0.4 mCi in 0.4 mL administered by periareolar or peritumoural route
Sentinel lymph node detection rate
Rate of detection of at least one sentinel lymph node by indocyanine green
Time frame: Time of Surgery
Age
Patient age
Time frame: At visit 1 (pre-operative consultation)
Height
Patient height
Time frame: At visit 1 (pre-operative consultation)
Weight
Patient weight
Time frame: At visit 1 (pre-operative consultation)
BMI
Patient BMI
Time frame: At visit 1 (pre-operative consultation)
Comorbidities
Comorbidities of interest
Time frame: At visit 1 (pre-operative consultation)
Menopause status
Menopause status
Time frame: At visit 1 (pre-operative consultation)
Prior excisional surgery
Prior excisional surgery on the breast
Time frame: At visit 1 (pre-operative consultation)
Surgery type planned
Type of breast surgery planned
Time frame: At visit 1 (pre-operative consultation)
Tumour size
Tumour size
Time frame: At visit 1 (pre-operative consultation)
Tumour grade
Tumour grade
Time frame: At visit 1 (pre-operative consultation)
Tumour stage
Tumour stage
Time frame: At visit 1 (pre-operative consultation)
Histological type
Tumour histological type
Time frame: At visit 1 (pre-operative consultation)
Hormone receptor status
Tumour hormone receptor status (estrogen receptors, progesterone receptors, and HER2 status)
Time frame: At visit 1 (pre-operative consultation)
Tumour laterality
Tumour laterality
Time frame: At visit 1 (pre-operative consultation)
Tumour quadrant
Tumour quadrant
Time frame: At visit 1 (pre-operative consultation)
Detection method
Method used to detect sentinel lymph node (indocyanine green alone or in combination with blue dye or 99mTc)
Time frame: Time of surgery
Indocyanine green dose
Dose of indocyanine green
Time frame: Time of surgery
Indocyanine green volume
Volume of indocyanine green
Time frame: Time of surgery
Injection site
Description of injection site
Time frame: Time of surgery
Number of injection sites
Number of injection sites
Time frame: Time of surgery
Route of injection
Route of injection (periareolar or peritumoural)
Time frame: Time of surgery
Detection equipment
Equipment used for detection of sentinel lymph node
Time frame: Time of surgery
Number of sentinel lymph node biopsies performed
Number of sentinel lymph node biopsies performed
Time frame: Time of surgery
Time from injection to visualization
Time from injection to visualization of first sentinel lymph node
Time frame: Time of surgery
Time from injection to end of biopsy
Time from injection to end of biopsy procedure
Time frame: Time of surgery
Number of sentinel lymph nodes detected
Number of sentinel lymph nodes detected (by all detection methods) per patient
Time frame: Time of surgery
Number of sentinel lymph nodes detected - indocyanine green
Number of sentinel lymph nodes detected (by indocyanine green) per patient
Time frame: Time of surgery
Number of sentinel lymph nodes detected - blue dye
Number of sentinel lymph nodes detected (by blue dye) per patient
Time frame: Time of surgery
Number of sentinel lymph nodes detected - 99mTc
Number of sentinel lymph nodes detected (by 99mTc) per patient
Time frame: Time of surgery
Adverse events
Number, frequency, grade, and outcomes of adverse events related to indocyanine green, using CTCAE v5 criteria/MedDRA
Time frame: From time of surgery up to 6 weeks post-surgery
Serious adverse events
Number frequency, and outcomes of serious adverse events related to indocyanine green, using CTCAE v5 criteria/MedDRA
Time frame: From time of surgery up to 6 weeks post-surgery
Changes in vital signs
Number of observed clinically significant changes in blood pressure, pulse rate, and respiratory rate
Time frame: From time of surgery up to 6 weeks post-surgery
Sentinel lymph node detection rate by obesity status
Rate of detection of at least one sentinel lymph node by indocyanine green in obese (BMI ≥30 kg/m2) vs non-obese (BMI ≤30 kg/m2) patients
Time frame: Time of surgery
Sentinel lymph node detection rate in early-stage breast cancer
Rate of detection of at least one sentinel lymph node by indocyanine green in patients with stage 1A, 1B, or 2A breast cancer
Time frame: Time of surgery
Sentinel lymph node detection rate by indocyanine green dose
Rate of detection of at least one sentinel lymph node by indocyanine green for patients receiving 5 mg dose vs 10 mg dose
Time frame: Time of surgery
Sentinel lymph node detection rate by injection route
Rate of detection of at least one sentinel lymph node by indocyanine green for patients injected via periareolar vs peritumoural vs subcutaneous route
Time frame: Time of surgery
Ran from Jun 2023 to primary completion in Nov 2023, 5 months.
Of 1,191 non-industry observational studies under Breast Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 139. This study's 5 months is below that.
Counting every sponsor, half of 1,380 studies reached it within 55 months; a quarter within 25 and three quarters within 126.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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BTG International Inc.