Clinical Trial Results:
Sentinel node in ovarian cáncer: tailoring clinical feasibility
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Summary
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EudraCT number |
2017-003683-12 |
Trial protocol |
ES |
Global end of trial date |
21 Aug 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
13 Feb 2022
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First version publication date |
13 Feb 2022
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Other versions |
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Summary report(s) |
SENTOV result publication |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
SENTOV
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Instituto de Investigación Sanitaria La Fe de Valencia
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Sponsor organisation address |
Avenida Fernando Abril Martorell, Torre 106 A 7planta, Valencia, Spain,
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Public contact |
Jose María Millan Salvador
, Instituto de Investigación Sanitaria La Fe, 34 961246611, investigacion_clinica@iislafe.es
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Scientific contact |
Jose María Millan Salvador, Instituto de Investigación Sanitaria La Fe, 34 961246611, investigacion_clinica@iislafe.es
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
06 Nov 2020
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
21 Aug 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To describe the feasibility of performing the Sentinel Node technique (Sentinel Node detection rate) in patients with previous ovarian surgery by injecting the tracer into the stump of the infundibular-pelvic ligament and uterus-ovarian ligament
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Protection of trial subjects |
The reference study was conducted in Spain under the legal framework of Royal Decree 1090/2015. It has been performed in accordance with the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects, adopted by the General Assembly of the World Medical Association (1996). In addition, the study has been conducted in accordance with the protocol, good clinical practice (GCP) in accordance with the guidelines of the international conference on harmonization (ICH) and regulatory requirements for participating institutions.
An appropriately performed informed consent has been used, in compliance with GCP according to ICH guidelines and approved by the CEIm of the Hospital Universitario y Politécnico La Fe. Prior to inclusion of subjects in the study, a copy of the CEIm-approved informed consent has been reviewed with the prospective participant, signed and dated. The investigator has provided a copy of each subject's signed informed consent form and has retained a copy in the subject's study file.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
23 Mar 2018
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 20
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Worldwide total number of subjects |
20
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EEA total number of subjects |
20
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
20
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Patients diagnosed with ovarian cancer at apparent stage I-II | |||||||||
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Pre-assignment
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Screening details |
Inclusion criteria: Signed informed consent prior to the performance of any procedure related to the clinical trial. Women 18 years of age or older at the time of inclusion. Patients with an anatomopathological diagnosis of malignant ovarian tumor in deferred study proposed for staging surgery or patients with tumor suspicious of malignancy | |||||||||
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Pre-assignment period milestones
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Number of subjects started |
20 | |||||||||
Number of subjects completed |
20 | |||||||||
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Period 1
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Period 1 title |
Group assignment (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Previous confirmed malignancy | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
m99Tc
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Investigational medicinal product code |
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Other name |
technetium 99m nanocolloid
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Pharmaceutical forms |
Powder for suspension for injection
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Routes of administration |
Injection , Intravenous use
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Dosage and administration details |
Subperitoneal injection 0.2ml of saline solution with 37 mBq
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Investigational medicinal product name |
Indocyanine green
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Injection
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Dosage and administration details |
Subperitoneal injection at a concentration of 1,25 mg/mL. One vial of 25 mg diluted in 20 ml of serum injecting extra 0,5 mL of the solution together with the radioactive colloid.
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Arm title
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Suspicious adnexal mass | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
m99Tc
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Investigational medicinal product code |
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Other name |
technetium 99m nanocolloid
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Pharmaceutical forms |
Powder for suspension for injection
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Routes of administration |
Injection , Intravenous use
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Dosage and administration details |
Subperitoneal injection 0.2ml of saline solution with 37 mBq
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Investigational medicinal product name |
Indocyanine green
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Injection
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Dosage and administration details |
Subperitoneal injection at a concentration of 1,25 mg/mL. One vial of 25 mg diluted in 20 ml of serum injecting extra 0,5 mL of the solution together with the radioactive colloid.
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Baseline characteristics reporting groups
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Reporting group title |
Previous confirmed malignancy
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Suspicious adnexal mass
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Previous confirmed malignancy
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Reporting group description |
- | ||
Reporting group title |
Suspicious adnexal mass
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Reporting group description |
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End point title |
Feasibility of performing the sentinel lymph node technique | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Perioperative length
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Statistical analysis title |
T-Test | |||||||||
Comparison groups |
Suspicious adnexal mass v Previous confirmed malignancy
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Number of subjects included in analysis |
20
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
≤ 0.05 | |||||||||
Method |
t-test, 1-sided | |||||||||
Parameter type |
Mean difference (final values) | |||||||||
Point estimate |
90
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Confidence interval |
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level |
95% | |||||||||
sides |
1-sided
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lower limit |
- | |||||||||
upper limit |
100 | |||||||||
Variability estimate |
Standard deviation
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Dispersion value |
1.5
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Adverse events information [1]
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Timeframe for reporting adverse events |
All events that meet the definition of an AA and occur within the period from the time the patient signs the informed consent form until 28 days after the end of treatment must be recorded.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||
Dictionary version |
24.1
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Reporting groups
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Reporting group title |
Study population
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Reporting group description |
- | ||||||||||||||||||||||||||||||||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: There are no non-serious adverse events recorded in the final result report |
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/32448808 |
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