Endometrial CancerPhase 2HYBRIDENDONODNCT04492995
Sentinel Node in Endometrial Cancer
A Phase 2 study testing injection via TUMIR of the tracer [99mTc] Tc-albumin nanocoloid-ICG (6 mCi, 4 ml) and injection via TUMIR of [99mTc] Tc-albumin nanocoloid (6mCi, 8ml). in people with Endometrial Cancer, run by Judit Pich Martínez at 1 site in Spain.
Trial summary
Phase II, open-label, randomized pilot study. Patients will be randomized (1:1) to receive for sentinel node screening: 1. Radiotracer (RT) via cervical administration and TUMIR 2. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- injection via TUMIR of the tracer [99mTc] Tc-albumin nanocoloid-ICG (6 mCi, 4 ml) and injection via TUMIR of [99mTc] Tc-albumin nanocoloid (6mCi, 8ml).
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 5 Oct 2020to 30 Sep 2023
- Phase
- Phase 2
- 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
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínic de Barcelona
Barcelona, 08036
Pilar Paredes, MD
Pilar Paredes, MD
About this study
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
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.
- Conditions
- Endometrial Cancer
- Being tested
- 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).
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Radiotracer + TUMIR | Active comparator | TUMIR = transvaginal ultrsound-guided myometrial injection Receives: 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 Receives: Diagnostic Test: injection via TUMIR of [99mTc] Tc-albumin nanocoloid (6mCi, 8ml). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with intraoperative detection of sentinel nodes
Measured: 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).
Measured: 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)
Measured: 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
Measured: 1 month
Number of false negative results after injection of the hybrid RT or RT by transvaginal ultrasound-guided myometrial injection (TUMIR).
Measured: 1 month
Difference in the number of sentinel nodes visualized after injection of the hybrid RT or RT between TUMIR lymphogammagraphy and cervical lymphogammagraphy
Measured: 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).
Measured: 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).
Measured: 1 month
Difference between the proportion of paraortic sentinel nodes detected after injection of each of the radiotracers (hybrid RT and RT) during surgery.
Measured: 1 month
Proportion of patients with hypersensitivity reactions related to injection of each of the two radiotracers (hybrid RT and RT).
Measured: 1 month
Proportion of patients with adverse events related to injection of one of the two radiotracers (hybrid RT and RT).
Measured: 1 month
Surgical detection time of sentinel nodes during intraoperative detection after injection of each of the two radiotracers (hybrid RT and RT).
Measured: 1 month
Histological data of the tumor: histology, tumor grade, tumor size and myometrial infiltration.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start5 Oct 2020
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial 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 2
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Judit Pich Martínez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Judit Pich Martínez, Fundacion Clinic per a la Recerca Biomédica
- Investigators
- Pilar Paredes, MD, Principal investigator, Hospital Clinic of BarcelonaSergi Vidal, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492995
- Sponsor's protocol ID
- HYBRID-ENDONODE
- Other IDs
- 2020-001970-31
- Acronym
- HYBRIDENDONOD
- Status last verified
- Sep 2023
- First submitted
- 27 Jul 2020
- Last updated
- 18 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38233608
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04492995
- Acronym / sponsor ID
- HYBRIDENDONOD / HYBRID-ENDONODE
- Conditions
- Endometrial Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Judit Pich MartínezUniversity, hospital or other
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 30 Jul 2020 (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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotracer + TUMIR | Active comparator | Diagnostic Test: injection via TUMIR of the tracer [99mTc] Tc-albumin nanocoloid-ICG (6 mCi, 4 ml)TUMIR = transvaginal ultrsound-guided myometrial injection |
| (Radiotraces + ICG) + TUMIR | Experimental | Diagnostic Test: injection via TUMIR of [99mTc] Tc-albumin nanocoloid (6mCi, 8ml).ICG =indocyanine green TUMIR = transvaginal ultrsound-guided myometrial injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| injection via TUMIR of the tracer [99mTc] Tc-albumin nanocoloid-ICG (6 mCi, 4 ml)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. | Diagnostic test | Radiotracer + TUMIR |
| injection via TUMIR of [99mTc] Tc-albumin nanocoloid (6mCi, 8ml).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. | Diagnostic test | (Radiotraces + ICG) + TUMIR |
Primary outcome
Proportion of patients with intraoperative detection of sentinel nodes
Time frame: 1 month
12 secondary outcomes
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
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
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
Number of false negative results after injection of the hybrid RT or RT by transvaginal ultrasound-guided myometrial injection (TUMIR).
Time frame: 1 month
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
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
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
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
Proportion of patients with hypersensitivity reactions related to injection of each of the two radiotracers (hybrid RT and RT).
Time frame: 1 month
Proportion of patients with adverse events related to injection of one of the two radiotracers (hybrid RT and RT).
Time frame: 1 month
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
Histological data of the tumor: histology, tumor grade, tumor size and myometrial infiltration.
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Derived from this study: PubMed 38233608van 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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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.
Pilar Paredes, MD principal investigator
Hospital Clinic of Barcelona
Sergi Vidal principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing injection via TUMIR of the tracer [99mTc] Tc-albumin nanocoloid-ICG (6 mCi, 4 ml) and injection via TUMIR of [99mTc] Tc-albumin nanocoloid (6mCi, 8ml). in people with Endometrial Cancer, run by Judit Pich Martínez at 1 site in Spain.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 18 Sep 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 Spain. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pilar Paredes, MD (+34932275400, pparedes@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with intraoperative detection of sentinel nodes (time frame: 1 month). 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 NCT04492995, which also lists 1 linked publication.
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 18 Sep 2023.