Sentinel node detection with 99Tc albumin nanocolloid and indocianine green (ICG) in patients with epithelial ovarian cancer in early stages. Pilot study.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacio De Recerca Clinic Barcelona-Institut D’investigacions Biomediques August Pi I Sunyer

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Neoplasms [C04], Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

Trial duration

6 Oct 2023 → ongoing

Decision date (initial)

2023-09-25

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Instituto de Salud Carlos III

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

To evaluate the diagnostic efficiency of both tracers in sentinel lymph node detection

Secondary objectives 7

1. To evaluate the diagnostic precision for the detection of sentinel lymph node in epithelial ovarian cancer in early stages.
2. To evaluate the lymphatic map in patients with epithelial ovarian cancer in early stages for each of the tracers (99Tc albumin nanocolloid and ICG)
3. To evaluate the anatomic distribution of 99mTC draining in the group of total patients included.
4. To evaluate the performance of intraoperative detector gamma probe and NIR camera in the display of ovarian lymphatic map.
5. To learn the anatomic distribution of sentinel lymph node and metastases.
6. To evaluate if sentinel lymph node ultrastadification improves micrometastases detection compared to conventional histology.
7. To evaluate the complications associated with each technique.

Conditions and MedDRA coding

Epithelial ovarian cancer in early stages.

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 1. 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 stadification indicated. 2. Absence of retroperitoneal ganglionary affectation and metastatic disease evaluated by preoperative imaging techniques. 3. Signing of informed consent by the patient or relative in charge. 4. 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 1

1. 1. Patients <18 years 2. Pregnancy or breastfeeding 3. Epithelial ovarian tumors stage FIGO III or IV. 4. Impossibility to obtain a biopsy from the tumor. 5. History of previous vascular surgery (cava vein, aorta, iliac blood vessels) or radiotherapy in pelvic or para-aortic area. 6. 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. 7. Patient not able to undergo surgery 8. Hypersensitivity to active principle, to sodium iodide or iodine allergy. 9. Patients with clinic hyperthyroidism, thyroid autonomous adenomas or focal and diffused autonomous alteration of thyroid gland

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Global detection rate of sentinel lymph node in patients having received both tracers.

Secondary endpoints 7

1. Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by morphologic characteristics, pathology results, FIGO stage, biochemistry results and surgical approach.
2. Detection rate and false negative rate according to each tracer, stratified by morphologic characteristics, pathology results, FIGO stage, biochemistry results and surgical approach.
3. Detection rate of sentinel lymph node with 99mTC in the group of patients having received the tracer.
4. Detection rate and false negative rate according to each detection technique used, stratified by morphologic characteristics, pathology results, FIGO stage, biochemistry results and surgical approach.
5. Anatomical location of sentinel lymph node according to each tracer and assessment of concordance between them.
6. Pathology ultrastadification evaluation.
7. Chirurgic and post-operative complications, directly or indirectly associated to the use of the tracers

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacio De Recerca Clinic Barcelona-Institut D’investigacions Biomediques August Pi I Sunyer

Sponsor organisation

Fundacio De Recerca Clinic Barcelona-Institut D’investigacions Biomediques August Pi I Sunyer

Address

Calle Rosellon 149-153

City

Barcelona

Postcode

08036

Country

Spain

Scientific contact point

Organisation

Fundacio De Recerca Clinic Barcelona-Institut D’investigacions Biomediques August Pi I Sunyer

Contact name

Laura Burunat

Public contact point

Organisation

Fundacio De Recerca Clinic Barcelona-Institut D’investigacions Biomediques August Pi I Sunyer

Contact name

Laura Burunat

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

2 submissions — initial application plus substantial / non-substantial modifications