Ovarian Epithelial CancerMelisa-IINCT05937620
Sentinel Node Detection With Technetium-99m Albumin Nanocolloid and ICG in Patients With Epithelial Ovarian Cancer
A study testing 99mTC nanocolloid albumin injection and ICG injection in people with Ovarian Epithelial Cancer, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
Trial summary
Study to evaluate the diagnostic precision of ICG and 99mTc nanocolloid albumin in sentinel lymph node detection in early ovarian epithelial cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Epithelial Cancer
- What is being tested?
- 99mTC nanocolloid albumin injection and ICG injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2023to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients with adnexal mass diagnosed with high suspicion of malignancy that will undergo intraoperative biopsy or patients with already diagnosed epithelial cancer in early stages in a previous surgery and confirmed by pathology with complete staging indicated.
- Absence of retroperitoneal ganglionary affectation and metastatic disease evaluated by preoperative imaging techniques.
- Signing of informed consent by the patient or relative in charge.
- Women with childbearing potential must compromise to use highly effective contraceptive methods (partner vasectomized, sexual abstinence) until the end of the study (last study visit).
Who cannot join
- Patients <18 years
- Pregnancy or breastfeeding
- Epithelial ovarian tumors stage FIGO III or IV.
- Impossibility to obtain a biopsy from the tumor.
- History of previous vascular surgery (cava vein, aorta, iliac blood vessels) or radiotherapy in pelvic or para-aortic area.
- Sentinel lymph node biopsy will not be performed if intraoperative histologic study shows a benign ovarian tumor, low malignancy potential tumor or expansive mucinous histology.
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- Patient not able to undergo surgery.
- Hypersensitivity to active principle, to sodium iodide or iodine allergy.
- Patients with clinic hyperthyroidism, thyroid autonomous adenomas or focal and diffused autonomous alteration of thyroid gland
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Laura Burunat
Barcelona, Catalonia, 08036
Laura B Burunat, 0034932275400 ext. 4198, burunat@recerca.clinic.cat
About this study
Official title: Sentinel Node Detection With Technetium-99m Albumin Nanocolloid and Indocyanine Green (ICG) in Patients With Epithelial Ovarian Cancer in Early Stages: Pilot Study
Study to evaluate the diagnostic precision of ICG and 99mTc nanocolloid albumin in sentinel lymph node detection in early ovarian epithelial cancer.
- Conditions
- Ovarian Epithelial Cancer
- Being tested
- 99mTC nanocolloid albumin injection, ICG injection
- Medical subject headings
- Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
99mTC nanocolloid albumin injectionDiagnostic test
All patients will receive an injection of both tracers in order to detect the sentinel lymph node
ICG injectionDiagnostic test
All patients will receive an injection of both tracers in order to detect the sentinel lymph node
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | All patients will receive an injection of ICG and an injection of 99mTc nanocolloid albumin Receives: Diagnostic Test: 99mTC nanocolloid albumin injection; Diagnostic Test: ICG injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the diagnostic efficiency of both tracers in sentinel lymph node detection
Global detection rate of sentinel lymph node in patients having received both tracers.
Measured: Through study completion (an average of 36 months)
Secondary outcomes (21)
Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to morphological characteristics
Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by morphologic characteristics.
Measured: Through study completion (an average of 36 months)
Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to pathology results.
Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by pathology results
Measured: Through study completion (an average of 36 months)
Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to International Federation of Gynecology and Obstetrics (FIGO) stage
Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by FIGO stage
Measured: Through study completion (an average of 36 months)
Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to biochemistry results.
Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by biochemistry results
Measured: Through study completion (an average of 36 months)
Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to surgical approach
Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by surgical approach
Measured: Through study completion (an average of 36 months)
Evaluation of anatomical distribution of 99mTC draining
Detection rate of sentinel lymph node with 99mTC in the group of patients having received the tracer
Measured: Through study completion (an average of 36 months)
Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to morphological characteristics.
Detection rate and false negative rate of intraoperative detector gamma probe,stratified by morphologic characteristics.
Measured: Through study completion (an average of 36 months)
Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to pathology results.
Detection rate and false negative rate of intraoperative detector gamma probe,stratified by pathology results.
Measured: Through study completion (an average of 36 months)
Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to FIGO stage.
Detection rate and false negative rate of intraoperative detector gamma probe,stratified by FIGO stage.
Measured: Through study completion (an average of 36 months)
Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to biochemistry results.
Detection rate and false negative rate of intraoperative detector gamma probe,stratified by biochemistry results.
Measured: Through study completion (an average of 36 months)
Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to surgical approach.
Detection rate and false negative rate of intraoperative detector gamma probe,stratified by surgical approach.
Measured: Through study completion (an average of 36 months)
Evaluation of the performance of intraoperative Near Infrared (NIR) camera in the display of ovarian lymphatic map according to morphological characteristics
Detection rate and false negative rate of intraoperative NIR camera,stratified by morphological characteristics
Measured: Through study completion (an average of 36 months)
Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to pathology results.
Detection rate and false negative rate of intraoperative NIR camera,stratified by pathology results.
Measured: Through study completion (an average of 36 months)
Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to FIGO stage.
Detection rate and false negative rate of intraoperative NIR camera,stratified by FIGO stage.
Measured: Through study completion (an average of 36 months)
Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to biochemistry results.
Detection rate and false negative rate of intraoperative NIR camera,stratified by biochemistry results.
Measured: Through study completion (an average of 36 months)
Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to surgical approach.
Detection rate and false negative rate of intraoperative NIR camera,stratified by surgical approach.
Measured: Through study completion (an average of 36 months)
Anatomical distribution of sentinel lymph node detected with ICG.
Anatomical location of sentinel lymph node according to ICG.
Measured: Through study completion (an average of 36 months)
Anatomical distribution of sentinel lymph node detected with 99mTC albumin nanocolloid.
Anatomical location of sentinel lymph node according to 99mTC albumin nanocolloid.
Measured: Through study completion (an average of 36 months)
Comparison of lymph node detection with both tracers.
Assessment of concordance of sentinel lymph node anatomical location detected with each tracer.
Measured: Through study completion (an average of 36 months)
Evaluation of ultra-staging in micrometastases detection compared to conventional histology.
Pathology ultra-staging evaluation.
The following classification will be considered according to the criteria of the American Joint Committee on Cancer (AJCC):
- Macrometastases: tumor infiltration > 2 mm in maximum diameter.
- Micrometastases: tumor infiltration between 0.2 and 2 mm in maximum diameter.
- Isolated tumor cells or isolated cell group (CTA, GCA): clusters of cells smaller than 0.2 mm
Measured: Through study completion (an average of 36 months)
Evaluation of the complications associated with each technique.
Chirurgic and post-operative complications, directly or indirectly associated to the use of the tracers.
Measured: Through study completion (an average of 36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start1 Sep 2023
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Epithelial 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Berta Diaz-Feijoo, Physician, Principal investigator, Hospital Clinic of BarcelonaAureli Torné, Physician, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937620
- Sponsor's protocol ID
- 2023-505667-37-00
- Other IDs
- 2023
- Acronym
- Melisa-II
- Status last verified
- Feb 2026
- First submitted
- 20 Jun 2023
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Node Detection With Technetium-99m Albumin Nanocolloid and Indocyanine Green (ICG) in Patients With Epithelial Ovarian Cancer in Early Stages: Pilot Study
- ClinicalTrials.gov ID
- NCT05937620
- Acronym / sponsor ID
- Melisa-II / 2023-505667-37-00
- Conditions
- Ovarian Epithelial Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 10 Jul 2023 (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.
Study to evaluate the diagnostic precision of ICG and 99mTc nanocolloid albumin in sentinel lymph node detection in early ovarian epithelial cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Diagnostic Test: 99mTC nanocolloid albumin injection, Diagnostic Test: ICG injectionAll patients will receive an injection of ICG and an injection of 99mTc nanocolloid albumin |
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)
- Patients with adnexal mass diagnosed with high suspicion of malignancy that will undergo intraoperative biopsy or patients with already diagnosed epithelial cancer in early stages in a previous surgery and confirmed by pathology with complete staging indicated.
- Absence of retroperitoneal ganglionary affectation and metastatic disease evaluated by preoperative imaging techniques.
- Signing of informed consent by the patient or relative in charge.
- Women with childbearing potential must compromise to use highly effective contraceptive methods (partner vasectomized, sexual abstinence) until the end of the study (last study visit).
Key exclusion criteria (9 listed)
- Patients <18 years
- Pregnancy or breastfeeding
- Epithelial ovarian tumors stage FIGO III or IV.
- Impossibility to obtain a biopsy from the tumor.
- History of previous vascular surgery (cava vein, aorta, iliac blood vessels) or radiotherapy in pelvic or para-aortic area.
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 |
|---|---|---|
| 99mTC nanocolloid albumin injectionAll patients will receive an injection of both tracers in order to detect the sentinel lymph node | Diagnostic test | Interventional arm |
| ICG injectionAll patients will receive an injection of both tracers in order to detect the sentinel lymph node | Diagnostic test | Interventional arm |
Primary outcome
Evaluation of the diagnostic efficiency of both tracers in sentinel lymph node detection
Time frame: Through study completion (an average of 36 months)
Global detection rate of sentinel lymph node in patients having received both tracers.
21 secondary outcomes
Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to morphological characteristics
Time frame: Through study completion (an average of 36 months)
Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to pathology results.
Time frame: Through study completion (an average of 36 months)
Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to International Federation of Gynecology and Obstetrics (FIGO) stage
Time frame: Through study completion (an average of 36 months)
Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to biochemistry results.
Time frame: Through study completion (an average of 36 months)
Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to surgical approach
Time frame: Through study completion (an average of 36 months)
Evaluation of anatomical distribution of 99mTC draining
Time frame: Through study completion (an average of 36 months)
Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to morphological characteristics.
Time frame: Through study completion (an average of 36 months)
Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to pathology results.
Time frame: Through study completion (an average of 36 months)
Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to FIGO stage.
Time frame: Through study completion (an average of 36 months)
Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to biochemistry results.
Time frame: Through study completion (an average of 36 months)
Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to surgical approach.
Time frame: Through study completion (an average of 36 months)
Evaluation of the performance of intraoperative Near Infrared (NIR) camera in the display of ovarian lymphatic map according to morphological characteristics
Time frame: Through study completion (an average of 36 months)
Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to pathology results.
Time frame: Through study completion (an average of 36 months)
Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to FIGO stage.
Time frame: Through study completion (an average of 36 months)
Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to biochemistry results.
Time frame: Through study completion (an average of 36 months)
Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to surgical approach.
Time frame: Through study completion (an average of 36 months)
Anatomical distribution of sentinel lymph node detected with ICG.
Time frame: Through study completion (an average of 36 months)
Anatomical distribution of sentinel lymph node detected with 99mTC albumin nanocolloid.
Time frame: Through study completion (an average of 36 months)
Comparison of lymph node detection with both tracers.
Time frame: Through study completion (an average of 36 months)
Evaluation of ultra-staging in micrometastases detection compared to conventional histology.
Time frame: Through study completion (an average of 36 months)
Evaluation of the complications associated with each technique.
Time frame: Through study completion (an average of 36 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
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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.
Berta Diaz-Feijoo, Physician principal investigator
Hospital Clinic of Barcelona
Aureli Torné, Physician 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 study testing 99mTC nanocolloid albumin injection and ICG injection in people with Ovarian Epithelial Cancer, run by Fundacion Clinic per a la Recerca Biomédica 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: looking for participants now, as of the sponsor's last update on 9 Feb 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Burunat, Graduate (0034 932275400 ext. 4198, burunat@recerca.clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the diagnostic efficiency of both tracers in sentinel lymph node detection (time frame: Through study completion (an average of 36 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2026.