Uterine Cervical NeoplasmsNCT05004623
Early Feasibility Study of the "Easy Light" Fluorecence Imaging System
A study testing Sentinel Lymph Node Biopsy in people with Uterine Cervical Neoplasms and Uterine Neoplasms, run by Professor Fernando Figueira Integral Medicine Institute at 1 site in Brazil.
Trial summary
This is an early feasibility study to evaluate the device functionality of an open-field handheld wireless fluorecence imaging system for detection of sentinel lymph nodes in women with cervical and uterine cancers who underwent open surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Cervical Neoplasms, Uterine Neoplasms
- What is being tested?
- Sentinel Lymph Node Biopsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteBrazil
- Study dates
- 26 May 2021to 6 Aug 2021
- 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 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with biopsy-proven cervical or uterine cancers;
- Clinical stage I or II, according to FIGO - The International Federation of Gynecology and Obstetrics;
- Indication for sentinel lymph node biopsy with or without complementary lymphadenectomy by her medical assistant;
- Performance status of 0-2;
- No synchronous malignancies or previous oncological treatments such as radiation or major abdominal surgery;
- Absence of neuro-psychiatric disorders, apparent or confirmed infections, history of drug allergies, limiting obesity for surgery, and pregnancy or breast feeding;
- Appropriated cardio-respiratory, hepato-renal and hematological reserves;
- Signing of the Consent Form.
Who cannot join
- 1. Perioperative impossibility to inject the fluorescent dye indocyanine green in the cervical region due to any locorregional reason.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
IMIP - Instituo de Medicina Integral Professor Fernando Figueira
Recife, Pernambuco, 50070-550
About this study
Official title: Early Feasibility Study of an Open-Field Handheld Wireless Fluorecence Imaging System for Detection of Sentinel Lymph Nodes in Women With Cervical and Uterine Cancers
This is an early feasibility study to evaluate the device functionality of an open-field handheld wireless fluorecence imaging system for detection of sentinel lymph nodes in women with cervical and uterine cancers who underwent open surgery.
Read the detailed description
This study was designed to clinically evaluate the functionality of an prototype of our near-infrared fluorescence device named Easy Light. In brief, this device is an open-field handheld wireless fluorecence imaging system that allows real-time visualization of fluorescent dyes such as indocyanine green (ICG) using smartphones and tablets. The handheld is a rechargeable device responsible for excitation of the operative field with infra-red lighting and for capturing the fluorescence emitted by de fluorescent dye to be visualized via wi-fi in the smartphones and tablets using a pre-installed application software. Following the standards of near-infrared fluorescence for detection of sentinel lymph nodes in gynecological malignancies, the hypothesis was the identification of sentinel lymph nodes after lymphatic mapping by interstitial indocyanine green injection in the cervix was feasible with the use of our device named Easy Light.
- Conditions
- Uterine Cervical Neoplasms, Uterine Neoplasms
- Being tested
- Sentinel Lymph Node Biopsy
- Keywords
- Sentinel Lymph Node Biopsy, Fluorescence, Indocyanine Green
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel Lymph Node BiopsyDevice
Detection of sentinel lymph nodes by indocyanine green (ICG) fluorescent dye technique, using a prototype of the Easy Light device.
| Study group | Role | What they receive |
|---|---|---|
| Sentinel Lymph Node Biopsy | Other | Sentinel lymph node biopsy by indocyanine green (ICG) fluorescent dye technique, using a prototype of the Easy Light device. Lymph node dissection in each hemipelvis should be performed as standard if no sentinel lymph node is detected. Decision of proceeding with complementary lymph node dissection after sentinel lymph node detection is a surgeon decision, according to his/her usual practice. Receives: Device: Sentinel Lymph Node Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ability to detect sentinel lymph nodes.
The ability to detect at least one sentinel lymph node per patient during open surgeries.
Measured: Intraoperativelly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start26 May 2021
- Primary completion27 Jul 2021
- Study completion6 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervical NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an early feasibility study.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Professor Fernando Figueira Integral Medicine Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thales Paulo Batista, Professor Fernando Figueira Integral Medicine Institute
- Investigators
- Thales P Batita, PhD, Principal investigator, IMIP, Department of Surgery/Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004623
- Sponsor's protocol ID
- 45814621.5.0000.5201
- Status last verified
- Aug 2021
- First submitted
- 16 Jun 2021
- Last updated
- 13 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study of an Open-Field Handheld Wireless Fluorecence Imaging System for Detection of Sentinel Lymph Nodes in Women With Cervical and Uterine Cancers
- ClinicalTrials.gov ID
- NCT05004623
- Acronym / sponsor ID
- 45814621.5.0000.5201
- Conditions
- Uterine Cervical Neoplasms, Uterine Neoplasms
- Keywords
- Sentinel Lymph Node Biopsy, Fluorescence, Indocyanine Green
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Professor Fernando Figueira Integral Medicine InstituteUniversity, hospital or other
- Study start
- 26 May 2021 (actual)
- Primary completion
- 27 Jul 2021 (actual)
- Study completion
- 6 Aug 2021 (actual)
- First posted
- 13 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an early feasibility study to evaluate the device functionality of an open-field handheld wireless fluorecence imaging system for detection of sentinel lymph nodes in women with cervical and uterine cancers who underwent open surgery.
Detailed description
This study was designed to clinically evaluate the functionality of an prototype of our near-infrared fluorescence device named Easy Light. In brief, this device is an open-field handheld wireless fluorecence imaging system that allows real-time visualization of fluorescent dyes such as indocyanine green (ICG) using smartphones and tablets. The handheld is a rechargeable device responsible for excitation of the operative field with infra-red lighting and for capturing the fluorescence emitted by de fluorescent dye to be visualized via wi-fi in the smartphones and tablets using a pre-installed application software. Following the standards of near-infrared fluorescence for detection of sentinel lymph nodes in gynecological malignancies, the hypothesis was the identification of sentinel lymph nodes after lymphatic mapping by interstitial indocyanine green injection in the cervix was feasible with the use of our device named Easy Light.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an early feasibility study.
| Arm | Type | Receives |
|---|---|---|
| Sentinel Lymph Node Biopsy | Other | Device: Sentinel Lymph Node BiopsySentinel lymph node biopsy by indocyanine green (ICG) fluorescent dye technique, using a prototype of the Easy Light device. Lymph node dissection in each hemipelvis should be performed as standard if no sentinel lymph node is detected. Decision of proceeding with complementary lymph node dissection after sentinel lymph node detection is a surgeon decision, according to his/her usual practice. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with biopsy-proven cervical or uterine cancers;
- Clinical stage I or II, according to FIGO - The International Federation of Gynecology and Obstetrics;
- Indication for sentinel lymph node biopsy with or without complementary lymphadenectomy by her medical assistant;
- Performance status of 0-2;
- No synchronous malignancies or previous oncological treatments such as radiation or major abdominal surgery;
Key exclusion criteria (1 listed)
- 1. Perioperative impossibility to inject the fluorescent dye indocyanine green in the cervical region due to any locorregional reason.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sentinel Lymph Node BiopsyDetection of sentinel lymph nodes by indocyanine green (ICG) fluorescent dye technique, using a prototype of the Easy Light device. | Device | Sentinel Lymph Node Biopsy |
Primary outcome
The ability to detect sentinel lymph nodes.
Time frame: Intraoperativelly
The ability to detect at least one sentinel lymph node per patient during open surgeries.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thales P Batita, PhD principal investigator
IMIP, Department of Surgery/Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sentinel Lymph Node Biopsy in people with Uterine Cervical Neoplasms and Uterine Neoplasms, run by Professor Fernando Figueira Integral Medicine Institute at 1 site in Brazil.
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 8 inclusion and 1 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: finished, as of the sponsor's last update on 13 Aug 2021. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ability to detect sentinel lymph nodes. (time frame: Intraoperativelly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2021.