NCT04492995

Brief Summary

Phase II, open-label, randomized pilot study. Patients will be randomized (1:1) to receive for sentinel node screening:

  1. 1.Radiotracer (RT) via cervical administration and TUMIR
  2. 2.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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2020

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 30, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

October 5, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

September 18, 2023

Status Verified

September 1, 2023

Enrollment Period

3 years

First QC Date

July 27, 2020

Last Update Submit

September 15, 2023

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with intraoperative detection of sentinel nodes

    1 month

Secondary Outcomes (12)

  • 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)

    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

  • +7 more secondary outcomes

Study Arms (2)

Radiotracer + TUMIR

ACTIVE COMPARATOR

TUMIR = transvaginal ultrsound-guided myometrial injection

Diagnostic Test: injection via TUMIR of the tracer [99mTc] Tc-albumin nanocoloid-ICG (6 mCi, 4 ml)

(Radiotraces + ICG) + TUMIR

EXPERIMENTAL

ICG =indocyanine green TUMIR = transvaginal ultrsound-guided myometrial injection

Diagnostic Test: injection via TUMIR of [99mTc] Tc-albumin nanocoloid (6mCi, 8ml).

Interventions

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.

Radiotracer + TUMIR
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.

(Radiotraces + ICG) + TUMIR

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38233608DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Pilar Paredes, MD

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

  • Sergi Vidal

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pilar Paredes, MD

CONTACT

+34932275400pparedes@clinic.cat

Sergi Vidal

CONTACT

+34932275400svidal@clinic.cat

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Research Manager

Study Record Dates

First Submitted

July 27, 2020

First Posted

July 30, 2020

Study Start

October 5, 2020

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

September 18, 2023

Record last verified: 2023-09

Locations

ES(1)