AzTrials
AzTrials

Ovarian CancerMELISANCT05184140

Mapping Sentinel Lymph Node in Initial Stages of Ovarian Cancer

A study testing Sentinel node detection in people with Ovarian Cancer and Sentinel Lymph Node, run by Hospital Clinic of Barcelona at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Epithelial ovarian cancer (EOC) diagnosed in the initial stage (stage I-II) require complete staging surgery to histologically assess the possible existence of peritoneal or lymph node disease. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Ovarian Cancer, Sentinel Lymph Node
What is being tested?
Sentinel node detection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteSpain
Study dates
1 Jan 2021to 1 May 2023
Phase
Interventional
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients with a diagnosis of adnexal mass with high suspicion of malignancy and frozen section examination will undergo the lymphatic map with a radiotracer.
  • Patients with intraoperative diagnosis of epithelial ovarian cancer will undergo the SLN exeresis with two tracers.
  • Patients with a delayed diagnosis of epithelial ovarian cancer who are candidates to undergo a re-staging surgery will undergo the SLN exeresis with two tracers.

Who cannot join

  • Advanced ovarian cancer (FIGO III/IV)
  • Patients <18 years
  • Pregnancy or lactation
  • Previous vascular surgery (cava, aorta, iliac vessels), lymphadenectomy (pelvic or paraortic) or radiotherapy (pelvic or paraortic field)
  • Severe adherent syndrome that prevents tracer injection
  • The SLN technique will not be performed in case of benign ovarian tumor in the frozen section or borderline tumor (since in these cases there is no clinical indication of performing a lymphadenectomy)
  • Non-operable patient
  • Previous adverse events to the radiotracer or ICG

Trial locations and contacts

1 site in 1 country.

Núria Agustí, MD contact

+34 932 27 54 00 ext. 5334

nagusti@clinic.cat

Pilar Paredes, PhD contact

pparedes@clinic.cat

Spain1 site, 1 recruiting

  • Núria Agustí Garcia

    Barcelona, 08014

    Núria Agustí Garcia, MD, +34627654987, nagusti@clinic.cat

    Recruiting

Other trials in Spain

About this study

Official title: MELISA Trial: Mapping sEntinel Lymph Node in Initial StAges of Ovarian Cancer

Epithelial ovarian cancer (EOC) diagnosed in the initial stage (stage I-II) require complete staging surgery to histologically assess the possible existence of peritoneal or lymph node disease.

Systematic pelvic and paraaortic lymphadenectomy in stage I-II EOC is essential since confirming the presence of lymph node metastases means re-staging the disease as stage III. This change of stage has important prognostic and therapeutic implications. However, the lymph node involvement rate is around 10-30% (average of 15%). Systematic pelvic and para-aortic lymphadenectomy carries a risk of intraoperative complications, as well as longer operative time, postoperative complications and longer hospital stay. Moreover, by now there is no evidence suggesting a possible therapeutic value.

Read more

The sentinel lymph node (SLN) detects the first level of lymph node drainage. The absence of metastases in the SLN predicts the absence of tumor infiltration of the rest of lymph nodes of the same anatomical region and allows to safely avoid lymphadenectomy and its associated morbidity. In addition, the exhaustive evaluation of the SLN by ultrastaging and immunohistochemical study allows to increase the detection of microscopic disease.

Sentinel lymph node (SLN) biopsy, implemented in clinical practice in other gynecological tumors (breast, vulva, cervix or endometrium), has been studied very little in the initial ovarian epithelial cancer. Unlike other gynecological tumors, there are multiple anatomical and technical aspects that largely explain this lack of information. The double ovarian vascularization that accompanies lymphatic drainage explains this higher complexity. Therefore, at the present time, the detection of SLN in the initial EOC remains an experimental area without applicability in clinical practice. There are multiple doubts and issues to be resolved regarding the different tracers, the site and time injection and the actual accuracy of the SLN versus the lymphadenectomy.

Read the detailed description

The objective of this study is to know the lymphatic drainage and, if the lesion is malignant, remove the sentinel lymph nodes to know if it can predict the involvement of the remaining lymph nodes to assess the possible applicability of SLN in clinical practice.

Study design:

  1. Evaluation of the ovarian lymphatic map: injection of radiotracer (99mTc-nanocolloid albumin) in patients with a diagnosis of adnexal mass with high suspicion of malignancy. Intraoperative lymphogammagraphy will be performed using a portable gammacamera. Patients with a delayed diagnosis of ovarian cancer who are candidates to undergo a re-staging surgery will be included.
  2. After the adnexectomy a frozen section will be performed to confirm the diagnosis of malignancy and then the ICG (Indocyanine green) tracer will be injected. Since the spread and persistence of the ICG in the lymph nodes is rapid, this tracer will be injected only after confirmation of EOC. Simultaneous screening with a gammadetector probe and NIR (near-infrared spectrum) camera will be used to proceed to the detection of SLN according to the lymphatic map previously.
  3. Ultrastaging of the SLN by applying hematoxylin and eosin staining (H\&E) and, in the absence of metastatic disease, evaluation by immunohistochemistry with cytokeratin AE1: AE3.
Being tested
Sentinel node detection
Keywords
Ovarian Cancer, Sentinel Lymph Node
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sentinel node detectionProcedure or surgery

    Also called Complete staging surgery

    Injection of the radiotracer to infundibulo-pelvic and utero-ovarian ligament in patients with high suspicion of malignancy adnexal mass. Injection of green indocyanine r to infundibulo-pelvic and utero-ovarian stumps only in case of malignancy after the adnexectomy.

    Sentinel node exeresis and a complete staging surgery (including pelvic and para-aortic lymphadenectomy) will be performed in patients with ovarian cancer diagnosis.

Study groups in NCT05184140
Study groupRoleWhat they receive
Adnexal mass with high suspicion of malignancyExperimentalAn ovarian lymphatic map will be performed in patients with adnexal masses suspected of malignancy. Sentinel node exeresis and a complete staging surgery (including pelvic and para-aortic lymphadenectomy) will be performed in patients with ovarian cancer confirmation including restaging surgeries.
Receives: Procedure: Sentinel node detection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Detection rate of sentinel node technique

    Detection of SLN in initial epithelial ovarian cancer by assessing the concordance of the result between the lymph node metastases and the lymphadenectomy

    Measured: Through study completion, an average of 2 years

Secondary outcomes (7)

  1. Tracer specific detection rate

    To know the global and specific SLN identification rate, depending on the type of tracer used.

    Measured: 2 years

  2. Tracer-related adverse events

    The number of patients with tracer-related adverse events

    Measured: 1 month

  3. False negative rate and negative predictive value

    Evaluate the existence of false negatives in metastatic involvement of the SLN and negative predictive value

    Measured: 2 years

  4. Anatomical location of the sentinel lymph node

    The aortic and pelvic region will be divided 13 regions

    Measured: 2 years

  5. Detection rate of gamma-camera, gamma-probe and Infrared fluorescence camera

    Evaluate the performance of intraoperative lymphoscintigraphy with gamma-camera, gamma-probe and Infrared fluorescence camera in the visualization of the ovarian lymphatic map.

    Measured: 2 years

  6. Surgical time extension performing SLN technique

    Evaluate the time it takes to perform the SLN technique

    Measured: 2 years

  7. Anatomopathological ultrastaging examination of the sentinel lymph node

    Evaluate if ultrastaging of the SLN improves the detection of micrometastases compared to conventional histology. Ultrastaging protocol will be performed, consisting of two consecutive histological sections (4 μm thick) obtained at regular intervals of 150 μm, performing 4 levels of each paraffin block. The first section will be stained with H\&E and the second section will be stained immunohistochemically with an AE1-AE3 anti-keratin antibody (Dako®).

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2022
  2. Study start1 Jan 2021
  3. Primary completion1 Apr 2023 (estimated)
  4. Study completion1 May 2023 (estimated)

Resources

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
Model description
Controlled, prospective, descriptive
Masking
None (open label)
Enrolment
62 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05184140
Sponsor's protocol ID
HCB/2021/0130
Acronym
MELISA
Status last verified
Mar 2023
First submitted
4 Dec 2021
Last updated
7 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The IPD will be shared only with those making official request to the study investigator

Questions about this trial

What is this clinical trial studying?

A study testing Sentinel node detection in people with Ovarian Cancer and Sentinel Lymph Node, run by Hospital Clinic of Barcelona 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 3 inclusion and 8 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 7 Mar 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.

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 Núria Agustí, MD (+34 932 27 54 00 ext. 5334, nagusti@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Detection rate of sentinel node technique (time frame: Through study completion, an average of 2 years). 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 NCT05184140.

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 7 Mar 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in