Back to resultsSentinel Node in Endometrial Cancer (HYBRIDENDONOD)
Primary Purpose
Endometrial Cancer
Status
Recruiting
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
injection via TUMIR of the tracer [99mTc] Tc-albumin nanocoloid-ICG (6 mCi, 4 ml)
injection via TUMIR of [99mTc] Tc-albumin nanocoloid (6mCi, 8ml).
Sponsored by
About this trial
This is an interventional screening trial for Endometrial Cancer
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years.
- Histological diagnosis of endometrial cancer with criteria of high risk according to the following criteria: - unfavorable histology according to FIGO (adenocarcinoma serous, clear cell, or carcinosarcoma) - nuclear grade 3 - suspected myometrial invasion> 50% by resonance magnetic (MR) or transvaginal ultrasound
- Women of childbearing age should have a transvaginal ultrasound who rule out pregnancy and must commit to using methods highly effective contraceptives (vasectomized couple and sexual abstinence) until the hysterectomy is performed.
- Patient who gives written informed consent.
Exclusion Criteria:
- Pregnancy or lactation.
- Suspected lymph node or distant metastatic disease in the preoperative study.
- History of previous surgery or radiotherapy in the pelvic and paraortic lymphatic drainage areas or nodal involvement of any other etiology.
- Body mass index (BMI) greater than 45 Kg / m2.
- Patients who, in the researcher's opinion, are not suitable for participate, regardless of reason, including medical or clinical, or participants potentially at risk of not comply with the study procedures.
- Known hypersensitivity to some of the active substances or excipients from RT or ICG (including previous history of hypersensitivity to products containing human albumin).
- Hypersensitivity to sodium iodide.
- Patients allergic to iodine.
- Patients with clinical hyperthyroidism, thyroid adenomas autonomic and diffuse focal and autonomic disturbances of the gland thyroid.
Sites / Locations
- Hospital Clínic de BarcelonaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Radiotracer + TUMIR
(Radiotraces + ICG) + TUMIR
Arm Description
TUMIR = transvaginal ultrsound-guided myometrial injection
ICG =indocyanine green TUMIR = transvaginal ultrsound-guided myometrial injection
Outcomes
Primary Outcome Measures
Proportion of patients with intraoperative detection of sentinel nodes
Secondary Outcome Measures
Number of sentinel nodes biopsied during surgery after injection of the [99mTc] hybrid radiotracer Tc-albumin nanocoloid-ICG (hybrid RT) or albumin nanocoloid (RT) radiotracer [99mTc] by myometrial injection guided by transvaginal ultrasound (TUMIR).
Number of sentinel lymph nodes with lymph node infiltration detected during surgery after injection of hybrid RT or RT by guided myometrial injection by transvaginal ultrasound (TUMIR)
Number of lymph nodes with lymph node infiltration detected in the piece of lymphadenectomy after injection of hybrid RT or RT by TUMIR injection lymphadenectomy after injection of hybrid RT or RT by TUMIR injection
Number of false negative results after injection of the hybrid RT or RT by transvaginal ultrasound-guided myometrial injection (TUMIR).
Difference in the number of sentinel nodes visualized after injection of the hybrid RT or RT between TUMIR lymphogammagraphy and cervical lymphogammagraphy
Difference in the drainage pattern of each radiotracer (hybrid RT and RT) between the cervical injection and transvaginal ultrasound-guided myometrial injection (TUMIR).
Causes of non-drainage of the hybrid RT or RT in the cervical injection or in the Transvaginal ultrasound-guided myometrial injection (TUMIR).
Difference between the proportion of paraortic sentinel nodes detected after injection of each of the radiotracers (hybrid RT and RT) during surgery.
Proportion of patients with hypersensitivity reactions related to injection of each of the two radiotracers (hybrid RT and RT).
Proportion of patients with adverse events related to injection of one of the two radiotracers (hybrid RT and RT).
Surgical detection time of sentinel nodes during intraoperative detection after injection of each of the two radiotracers (hybrid RT and RT).
Histological data of the tumor: histology, tumor grade, tumor size and myometrial infiltration.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04492995
Brief Title
Sentinel Node in Endometrial Cancer
Acronym
HYBRIDENDONOD
Official Title
Sentinel Node in Endometrial Cancer by Detection of Hybrid ([99mTc] Tc-albumin Nanocoloid-ICG). A Comparative Pilot Study Between the Lymphatic Map Derived From the Cervical Puncture Versus Myometrial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Judit Pich Martínez
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Phase II, open-label, randomized pilot study.
Patients will be randomized (1:1) to receive for sentinel node screening:
Radiotracer (RT) via cervical administration and TUMIR
Combination of RT with Indocyanine Green (RT + ICG) via cervical administration and TUMIR Patients will be followed up to 1 month after the last administration of radiotracer 70 patients will be included into the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Radiotracer + TUMIR
Arm Type
Active Comparator
Arm Description
TUMIR = transvaginal ultrsound-guided myometrial injection
Arm Title
(Radiotraces + ICG) + TUMIR
Arm Type
Experimental
Arm Description
ICG =indocyanine green TUMIR = transvaginal ultrsound-guided myometrial injection
Intervention Type
Diagnostic Test
Intervention Name(s)
injection via TUMIR of the tracer [99mTc] Tc-albumin nanocoloid-ICG (6 mCi, 4 ml)
Intervention Description
The day before the surgery, a new scan (planar and SPECT / CT) will be performed after the injection via TUMIR of the tracer [99mTc] Tc-albumin nanocoloid-ICG (6 mCi, 4 ml) or the injection via TUMIR of [99mTc] Tc-albumin nanocoloid (6mCi, 8ml).
The two lymphatic maps will be compared and the number of sentinel nodes identified in each study and the territories of drainage and the difference between them (in number and territories) will be established.
On the day of surgery, a cervical injection of methylene blue will be performed at the start of surgery according to usual methodology (2 ml diluted to 50%). Intraoperative detection of the sentinel nodes will take place by visual inspection, using the gammadetector probe and NIR optics. Sentinel node biopsies will be processed according to the usual processing methodology and analysis for the detection of metastases.
Intervention Type
Diagnostic Test
Intervention Name(s)
injection via TUMIR of [99mTc] Tc-albumin nanocoloid (6mCi, 8ml).
Intervention Description
The day before the surgery, a new scan (planar and SPECT / CT) will be performed after the injection via TUMIR of the tracer [99mTc] Tc-albumin nanocoloid-ICG (6 mCi, 4 ml) or the injection via TUMIR of [99mTc] Tc-albumin nanocoloid (6mCi, 8ml).
The two lymphatic maps will be compared and the number of sentinel nodes identified in each study and the territories of drainage and the difference between them (in number and territories) will be established.
On the day of surgery, a cervical injection of methylene blue will be performed at the start of surgery according to usual methodology (2 ml diluted to 50%). Intraoperative detection of the sentinel nodes will take place by visual inspection, using the gammadetector probe and NIR optics. Sentinel node biopsies will be processed according to the usual processing methodology and analysis for the detection of metastases.
Primary Outcome Measure Information:
Title
Proportion of patients with intraoperative detection of sentinel nodes
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Number of sentinel nodes biopsied during surgery after injection of the [99mTc] hybrid radiotracer Tc-albumin nanocoloid-ICG (hybrid RT) or albumin nanocoloid (RT) radiotracer [99mTc] by myometrial injection guided by transvaginal ultrasound (TUMIR).
Time Frame
1 month
Title
Number of sentinel lymph nodes with lymph node infiltration detected during surgery after injection of hybrid RT or RT by guided myometrial injection by transvaginal ultrasound (TUMIR)
Time Frame
1 month
Title
Number of lymph nodes with lymph node infiltration detected in the piece of lymphadenectomy after injection of hybrid RT or RT by TUMIR injection lymphadenectomy after injection of hybrid RT or RT by TUMIR injection
Time Frame
1 month
Title
Number of false negative results after injection of the hybrid RT or RT by transvaginal ultrasound-guided myometrial injection (TUMIR).
Time Frame
1 month
Title
Difference in the number of sentinel nodes visualized after injection of the hybrid RT or RT between TUMIR lymphogammagraphy and cervical lymphogammagraphy
Time Frame
1 month
Title
Difference in the drainage pattern of each radiotracer (hybrid RT and RT) between the cervical injection and transvaginal ultrasound-guided myometrial injection (TUMIR).
Time Frame
1 month
Title
Causes of non-drainage of the hybrid RT or RT in the cervical injection or in the Transvaginal ultrasound-guided myometrial injection (TUMIR).
Time Frame
1 month
Title
Difference between the proportion of paraortic sentinel nodes detected after injection of each of the radiotracers (hybrid RT and RT) during surgery.
Time Frame
1 month
Title
Proportion of patients with hypersensitivity reactions related to injection of each of the two radiotracers (hybrid RT and RT).
Time Frame
1 month
Title
Proportion of patients with adverse events related to injection of one of the two radiotracers (hybrid RT and RT).
Time Frame
1 month
Title
Surgical detection time of sentinel nodes during intraoperative detection after injection of each of the two radiotracers (hybrid RT and RT).
Time Frame
1 month
Title
Histological data of the tumor: histology, tumor grade, tumor size and myometrial infiltration.
Time Frame
1 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years.
Histological diagnosis of endometrial cancer with criteria of high risk according to the following criteria: - unfavorable histology according to FIGO (adenocarcinoma serous, clear cell, or carcinosarcoma) - nuclear grade 3 - suspected myometrial invasion> 50% by resonance magnetic (MR) or transvaginal ultrasound
Women of childbearing age should have a transvaginal ultrasound who rule out pregnancy and must commit to using methods highly effective contraceptives (vasectomized couple and sexual abstinence) until the hysterectomy is performed.
Patient who gives written informed consent.
Exclusion Criteria:
Pregnancy or lactation.
Suspected lymph node or distant metastatic disease in the preoperative study.
History of previous surgery or radiotherapy in the pelvic and paraortic lymphatic drainage areas or nodal involvement of any other etiology.
Body mass index (BMI) greater than 45 Kg / m2.
Patients who, in the researcher's opinion, are not suitable for participate, regardless of reason, including medical or clinical, or participants potentially at risk of not comply with the study procedures.
Known hypersensitivity to some of the active substances or excipients from RT or ICG (including previous history of hypersensitivity to products containing human albumin).
Hypersensitivity to sodium iodide.
Patients allergic to iodine.
Patients with clinical hyperthyroidism, thyroid adenomas autonomic and diffuse focal and autonomic disturbances of the gland thyroid.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pilar Paredes, MD
Phone
+34932275400
Email
pparedes@clinic.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Sergi Vidal
Phone
+34932275400
Email
svidal@clinic.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pilar Paredes, MD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sergi Vidal
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pilar Paredes, MD
First Name & Middle Initial & Last Name & Degree
Pilar Paredes, MD
First Name & Middle Initial & Last Name & Degree
Sergi Vidal
12. IPD Sharing Statement
Learn more about this trial
Sentinel Node in Endometrial Cancer
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