Clinical trial • Phase III • Oncology
PERTECHNETATE (99MTC) SODIUM for Ovarian cancer|Early-stage ovarian cancer
Phase III trial of PERTECHNETATE (99MTC) SODIUM for Ovarian cancer|Early-stage ovarian cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Ovarian cancer|Early-stage ovarian cancer
- Trial Stage
- Phase III
- Drug Modality
- Radiopharmaceutical|Peptide/protein/enzyme|Diagnostic agent
Key dates
- Initial CTIS Submission Date
- 15-05-2025
- First CTIS Authorization Date
- 22-07-2025
Trial design
Pelvic/aortic lymphadenectomy (Gold Standard) — surgical lymphadenectomy comparator (not a drug comparator).-controlled Phase III trial in Spain.
- Comparator
- Pelvic/aortic lymphadenectomy (Gold Standard) — surgical lymphadenectomy comparator (not a drug comparator).
- Target Sample Size
- 200
Eligibility
Recruits 200 Vulnerable population not selected; participants must provide signed informed consent prior to any procedure; participants under 18 are excluded; no assent process described..
- Pregnancy Exclusion
- Pregnancy/Breastfeeding.
- Vulnerable Population
- Vulnerable population not selected; participants must provide signed informed consent prior to any procedure; participants under 18 are excluded; no assent process described.
Inclusion criteria
- {"criterion_text":"-Signed informed consent prior to the performance of any procedure related to the clinical trial."}
- {"criterion_text":"-Female, 18 years of age or older at the time of inclusion."}
- {"criterion_text":"-Patients with an anatomopathological diagnosis of malignant ovarian tumor in a deferred study (any epithelial histology), in apparent early stage FIGO I-II, proposed for staging surgery, or patients with suspected malignant ovarian tumor in apparent early stage FIGO I-II, who will undergo exploratory laparotomy and operative biopsy, and if positive, will undergo staging surgery."}
Exclusion criteria
- {"criterion_text":"-Failure to obtain informed consent or revocation of informed consent."}
- {"criterion_text":"-Under 18 years of age at the time of inclusion."}
- {"criterion_text":"-Previous history of vascular surgery on the aorta, vena cava, or pelvic vessels."}
- {"criterion_text":"-Previous pelvic or paraaortic lymphatic surgery."}
- {"criterion_text":"-Previous lymphoma."}
- {"criterion_text":"-Previous abdomino-pelvic tumor."}
- {"criterion_text":"-Previous allergy to Tc99 or ICG."}
- {"criterion_text":"-Pregnancy/Breastfeeding."}
Endpoints
Primary endpoints
- {"endpoint_text":"-Negative predictive value of the sentinel lymph node technique.","definition_or_measurement_approach":"Determined using pelvic/aortic lymphadenectomy as the Gold Standard to detect lymph node metastases."}
Secondary endpoints
- {"endpoint_text":"-Tumor size.","definition_or_measurement_approach":""}
- {"endpoint_text":"-Tumor location.","definition_or_measurement_approach":""}
- {"endpoint_text":"-Injection site.","definition_or_measurement_approach":""}
- {"endpoint_text":"-Type of tracer used.","definition_or_measurement_approach":""}
- {"endpoint_text":"-Injection-detection interval.","definition_or_measurement_approach":""}
- {"endpoint_text":"-Detection method.","definition_or_measurement_approach":""}
- {"endpoint_text":"-Anatomical location of the sentinel node.","definition_or_measurement_approach":""}
- {"endpoint_text":"-Number of detected sentinel lymph nodes.","definition_or_measurement_approach":""}
- {"endpoint_text":"-Number of detected lymph nodes.","definition_or_measurement_approach":""}
- {"endpoint_text":"-Histological type of detected sentinel lymph nodes.","definition_or_measurement_approach":""}
- {"endpoint_text":"-Degree of differentiation of detected sentinel lymph nodes.","definition_or_measurement_approach":""}
- {"endpoint_text":"-Lymphovascular invasion of detected sentinel lymph nodes.","definition_or_measurement_approach":""}
- {"endpoint_text":"-Ultrastaging of detected sentinel lymph nodes.","definition_or_measurement_approach":""}
- {"endpoint_text":"-Binary classification of detected sentinel lymph nodes.","definition_or_measurement_approach":""}
- {"endpoint_text":"-Histological result of detected sentinel lymph nodes.","definition_or_measurement_approach":""}
- {"endpoint_text":"-FIGO stage of detected sentinel lymph nodes.","definition_or_measurement_approach":""}
- {"endpoint_text":"-Surgical procedure performed.","definition_or_measurement_approach":""}
- {"endpoint_text":"-Intraoperative complications.","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 200
- Recruitment Window Months
- 36
- Consent Approach
- Signed informed consent required from each participant prior to any trial procedure; under-18s excluded; subject information and informed consent form documents are listed (L1), but languages available are not specified in the record.
Geography
- Total Number Of Sites
- 12
- Total Number Of Participants
- 200
Spain
- Earliest CTIS Part Ii Submission Date
- 02-06-2025
- Latest Decision Or Authorization Date
- 22-07-2025
- Processing Time Days
- 50
- Number Of Sites
- 12
- Number Of Participants
- 200
Sites
- Site Name
- University Hospital Son Espases
- Department Name
- Ginecología
- Principal Investigator Name
- Anna Torrent Colomer
- Principal Investigator Email
- atorrent7@gmail.com
- Contact Person Name
- Anna Torrent Colomer
- Contact Person Email
- atorrent7@gmail.com
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Ginecología
- Principal Investigator Name
- Enrique María Chacón Cruz
- Principal Investigator Email
- e.chaconcruz@gmail.com
- Contact Person Name
- Enrique María Chacón Cruz
- Contact Person Email
- e.chaconcruz@gmail.com
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Ginecología
- Principal Investigator Name
- Víctor Lago Leal
- Principal Investigator Email
- lago_vic@gva.com
- Contact Person Name
- Víctor Lago Leal
- Contact Person Email
- lago_vic@gva.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Ginecología
- Principal Investigator Name
- Álvaro Tejerizo García
- Principal Investigator Email
- alvaro.tejerizo@salud.madrid.org
- Contact Person Name
- Álvaro Tejerizo García
- Contact Person Email
- alvaro.tejerizo@salud.madrid.org
- Site Name
- Hospital Universitario De Navarra
- Department Name
- Ginecología
- Principal Investigator Name
- Juan Carlos Muruzabal Torquemada
- Principal Investigator Email
- jc.muruzabal.torquemada@cfnavarra.es
- Contact Person Name
- Juan Carlos Muruzabal Torquemada
- Contact Person Email
- jc.muruzabal.torquemada@cfnavarra.es
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Ginecología
- Principal Investigator Name
- Jesús Utrilla-Layna Trigo
- Principal Investigator Email
- jesus.utrilla.layna@gmail.com
- Contact Person Name
- Jesús Utrilla-Layna Trigo
- Contact Person Email
- jesus.utrilla.layna@gmail.com
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Ginecología
- Principal Investigator Name
- Enrique María Chacón Cruz
- Principal Investigator Email
- e.chaconcruz@gmail.com
- Contact Person Name
- Enrique María Chacón Cruz
- Contact Person Email
- e.chaconcruz@gmail.com
- Site Name
- Hospital Universitario La Paz
- Department Name
- Gi
- Principal Investigator Name
- Mª Dolores Diestro Tejeda
- Principal Investigator Email
- mdolores.diestro@salud.madrid.org
- Contact Person Name
- Mª Dolores Diestro Tejeda
- Contact Person Email
- mdolores.diestro@salud.madrid.org
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Ginecología
- Principal Investigator Name
- Berta Díaz Feijoo
- Principal Investigator Email
- bertadiazfeijoo@gmail.com
- Contact Person Name
- Berta Díaz Feijoo
- Contact Person Email
- bertadiazfeijoo@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Ginecología
- Principal Investigator Name
- Martina Aida Ángeles Fité
- Principal Investigator Email
- martinaangeles22@hotmail.com
- Contact Person Name
- Martina Aida Ángeles Fité
- Contact Person Email
- martinaangeles22@hotmail.com
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- Ginecología
- Principal Investigator Name
- Claudia Sánchez-Arévalo Crespo
- Principal Investigator Email
- claudiasanchezarev@gmail.com
- Contact Person Name
- Claudia Sánchez-Arévalo Crespo
- Contact Person Email
- claudiasanchezarev@gmail.com
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Ginecología
- Principal Investigator Name
- Amanda Veiga Fernández
- Principal Investigator Email
- amanda.veiga@salud.madrid.org
- Contact Person Name
- Amanda Veiga Fernández
- Contact Person Email
- amanda.veiga@salud.madrid.org
Sponsor
Primary sponsor
- Full Name
- IIS La Fe
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- PERTECHNETATE (99MTC) SODIUM
- Active Substance
- PERTECHNETATE (99MTC) SODIUM
- Modality
- Radiopharmaceutical
- Routes Of Administration
- PERITUMORAL USE
- Route
- PERITUMORAL USE
- Maximum Dose
- 200 MBq
- Investigational Product Name
- HUMAN SERUM ALBUMIN
- Active Substance
- HUMAN SERUM ALBUMIN
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- PERITUMORAL USE
- Route
- PERITUMORAL USE
- Maximum Dose
- 200 MBq
- Investigational Product Name
- INDOCYANINE GREEN
- Active Substance
- INDOCYANINE GREEN
- Modality
- Diagnostic agent
- Routes Of Administration
- PERITUMORAL USE
- Route
- PERITUMORAL USE
- Maximum Dose
- 5 mg/kg
Related trials
Other published trials that may interest you.
- GDC-9545 for Locally advanced or metastatic estrogen receptor-positive breast cancer
- Abemaciclib for Stage IV lung cancer | Breast cancer
- BGB-43395 for Advanced or metastatic solid tumors | Hormone receptor positive HER2 negative breast cancer
- AZD9833 for Estrogen receptor-positive HER2-negative advanced breast cancer
- Pembrolizumab for Classical Hodgkin lymphoma | Melanoma | Solid tumours (MSI-H/dMMR) | Solid tumours (TMB-H)