New dye combo could spare ovarian cancer patients unnecessary surgery
NCT ID NCT05937620
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study is testing whether a combination of two dyes (technetium-99m albumin nanocolloid and indocyanine green) can accurately identify the first lymph node where ovarian cancer might spread. The goal is to improve surgical staging and potentially avoid removing many lymph nodes. The study will enroll 62 women with early-stage epithelial ovarian cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Technetium-99m albumin nanocolloid and indocyanine green (ICG)
- What this could lead to
- If successful, this could lead to a more precise and less invasive way to stage early ovarian cancer, potentially reducing the need for extensive lymph node removal.
- What could go wrong
- This is a small pilot study (62 participants) focused on diagnostic accuracy, not treatment. The tracers may not detect all affected nodes, and results may not apply to later-stage cancers.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 62 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2023
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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). Exclusion Criteria: * 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. * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Laura Burunat
RECRUITINGBarcelona, Catalonia, 08036, Spain
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