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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001970-31 | EudraCT Number |
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Phase II, open-label, randomized pilot study.
Patients will be randomized (1:1) to receive for sentinel node screening:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotracer + TUMIR | Active Comparator | TUMIR = transvaginal ultrsound-guided myometrial injection |
|
| (Radiotraces + ICG) + TUMIR | Experimental | ICG =indocyanine green TUMIR = transvaginal ultrsound-guided myometrial injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| injection via TUMIR of the tracer [99mTc] Tc-albumin nanocoloid-ICG (6 mCi, 4 ml) | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with intraoperative detection of sentinel nodes | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 1 month | |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pilar Paredes, MD | Contact | +34932275400 | pparedes@clinic.cat | |
| Sergi Vidal | Contact | +34932275400 | svidal@clinic.cat |
| Name | Affiliation | Role |
|---|---|---|
| Pilar Paredes, MD | Hospital Clinic of Barcelona | Principal Investigator |
| Sergi Vidal | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnic de Barcelona | Recruiting | Barcelona | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38233608 | Derived | van Oosterom MN, Diaz-Feijoo B, Santisteban MI, Sanchez-Izquierdo N, Perissinotti A, Glickman A, Marina T, Torne A, van Leeuwen FWB, Vidal-Sicart S. Steerable DROP-IN radioguidance during minimal-invasive non-robotic cervical and endometrial sentinel lymph node surgery. Eur J Nucl Med Mol Imaging. 2024 Aug;51(10):3089-3097. doi: 10.1007/s00259-023-06589-3. Epub 2024 Jan 18. |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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|
| injection via TUMIR of [99mTc] Tc-albumin nanocoloid (6mCi, 8ml). | Diagnostic Test | 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. |
|
| 1 month |
| 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 | 1 month |
| Number of false negative results after injection of the hybrid RT or RT by transvaginal ultrasound-guided myometrial injection (TUMIR). | 1 month |
| Difference in the number of sentinel nodes visualized after injection of the hybrid RT or RT between TUMIR lymphogammagraphy and cervical lymphogammagraphy | 1 month |
| Difference in the drainage pattern of each radiotracer (hybrid RT and RT) between the cervical injection and transvaginal ultrasound-guided myometrial injection (TUMIR). | 1 month |
| Causes of non-drainage of the hybrid RT or RT in the cervical injection or in the Transvaginal ultrasound-guided myometrial injection (TUMIR). | 1 month |
| Difference between the proportion of paraortic sentinel nodes detected after injection of each of the radiotracers (hybrid RT and RT) during surgery. | 1 month |
| Proportion of patients with hypersensitivity reactions related to injection of each of the two radiotracers (hybrid RT and RT). | 1 month |
| Proportion of patients with adverse events related to injection of one of the two radiotracers (hybrid RT and RT). | 1 month |
| Surgical detection time of sentinel nodes during intraoperative detection after injection of each of the two radiotracers (hybrid RT and RT). | 1 month |
| Histological data of the tumor: histology, tumor grade, tumor size and myometrial infiltration. | 1 month |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |