Cervical CancersSLNNCT06697054
Sentinel Lymph Node (SLN) Mapping with Charcoal Carbon Dye in Early Stage Cervical Cancer
A study testing Sentinel node biopsy with either ICG or carbon dye injection to cervix in people with Cervical Cancers, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the present study is to compare the efficacy of charcoal carbon dye (CCD) in sentinel lymph node mapping compared to indocyanine green (ICG) mapping regarding detection rates, sensitivity, specificity, negative and positive predictive values in early stage cervical cancers (IA2 - IB2). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancers
- What is being tested?
- Sentinel node biopsy with either ICG or carbon dye injection to cervix
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 May 2024to 12 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 1.Pervious radiotherapy 2.Age less than 18 3.Previous pelvic retroperitoneal surgery
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Med Fac Dept. of Obstet and Gynecol. Division of Gynecologic Oncology
Istanbul, Turkey
About this study
Official title: Use of Charcoal Carbon Dye in Sentinel Lymph Node (SLN) Mapping in Early Stage Cervical Cancer
The aim of the present study is to compare the efficacy of charcoal carbon dye (CCD) in sentinel lymph node mapping compared to indocyanine green (ICG) mapping regarding detection rates, sensitivity, specificity, negative and positive predictive values in early stage cervical cancers (IA2 - IB2).
Read the detailed description
Cervical cancer continues to be a global health problem despite the advances in prevention, screening and treatment in preinvasive stages. Although radiotherapy is the mainstay of treatment across all stages, surgery with radical and non-radical hysterectomy with pelvic lymph node evaluation is preferred in younger women with early stage cervical cancer who wants to preserve ovarian and sexual functions that may otherwise be hampered by radiotherapy. Lymph node evaluation is critical during and/or after surgery (usually before hysterectomy) and offered by global institutions since hysterectomy during surgery is abandoned in case of a metastasis in pelvic / paraaortic lymph node(s) and/or necessities primary chemoradiation or adjuvant therapy as a therapeutic modality.
During the last 10-15 years surgical sentinel lymph node (SLN) evaluation instead of complete dissection pelvic / paraaortic lymphadenectomy has gained popularity with equal success, especially in cervical tumors with less than 2-4 cm in diameter. Besides, all other advantages of sentinel lymph node evaluation is alike the advantages of other sentinel lymph node evaluation in various other cancers (vulva, breast, endometrial cancers..) with less morbidity such as less vascular injury, lymphedema, lymphocyst formation and etc. Various tracers have been used for sentinel lymph node detection in cervical cancer surgery but indocyanine green (ICG) use has surpassed other SLN mapping tracers and methods and it is the most common agent for detecting SLN in gynecologic oncology. However, it needs a fairly expensive equipment and expertise either by laparoscopy or laparotomy. In the present study, investigators are planning to use charcoal carbon dye (CCD) in addition to ICG as their usual method for SLN mapping. CCD is commonly used by general surgeons for marking of colon during preoperative colonoscopy to delineate the point of resection in surgery for colorectal resection. It is cheap and does not require special equipment and easy to learn. CCD is planned to be given just as the same as giving ICG to the cervix with 1 cc injection at each site of external os (3 and 9 o'clock position, 0.5 cc given to submucosal area and 0.5 given stroma of cervix). 20 minutes following the injection of both agents, laparoscopic dissection of retroperitoneal area will be performed to detect pelvic and paraaortic sentinel lymph nodes (up to inferior mesenteric artery) with ICG and/or CCD.
The aim of the present study is to compare the efficacy of CCD in sentinel lymph node mapping compared to ICG mapping regarding detection rates, sensitivity, specificity, negative and positive predictive values in early stage cervical cancers (IA2 - IB2).
- Conditions
- Cervical Cancers
- Being tested
- Sentinel node biopsy with either ICG or carbon dye injection to cervix
- Keywords
- cervical cancer, indocyanine green, ICG, carbon dye, sentinel lymph node
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel node biopsy with either ICG or carbon dye injection to cervixDiagnostic test
Either laparatomy or laparoscopy wil be performed to detect sentinel node stained with either ICG or carbon dye injected to cervix. A hemipelvis in which a sentinel is not found will be subjected to full lymphadenectomy.
| Study group | Role | What they receive |
|---|---|---|
| Two different tracers as a sentinel lymph node agent will be compared in early cervical cancer | Experimental | Two different tracers, one charcoal carbon dye and other indocyanine used as sentinel lymph node agent will be compared in early cervical cancer in terms of detection rates, sensitivity, specificity, negative and positive predictive value. Both tracers will be used in the patient. Receives: Diagnostic Test: Sentinel node biopsy with either ICG or carbon dye injection to cervix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of sentinel lymph node(s)
Detection rate of sentinel lymph node(s) either by carbon dye or ICG unilaterally or bilaterally will be recorded and compared.
Measured: Two years
Specifity of sentinel lymph node mapping by carbon dye or ICG
Sensitivities of both tracers for malignancy will be compared to each other
Measured: Two years
Sensitivity of both tracers will be compared.
Sensitivity of both tracers will be compared for malignant metastasis
Measured: Two years
Sensitivity of both tracers will be compared.
Positive and negative predictive values of both tracers for malignant metastasis will be compared.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start12 May 2024
- Primary completion12 May 2026 (estimated)
- Study completion12 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cervical CancersStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single arm interventional study aiming at the comparison of the effectiveness of detection for sentinel lymph node biopsy using charcoal carbon dye compared to classic indocyanine (ICG) tracer in early stage cervical cancer. Sentinel lymph node detection rates of both tracers in pelvic, obturator and inframesenteric para-aortic whteher bilateral/ unilateral) will be compared in addition to sensitivity, specificity and negative and positive predictive value.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Albayrak, Istanbul University
- Investigators
- Yavuz Salihoglu, Prof. Dr., Study director, ISTANBUL UNİVERSİTY MED FAC DEPT. OF OBSTET AND GYNECOL. DIVISION OF GYNECOLOGİC ONCOLOGY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697054
- Sponsor's protocol ID
- 2024/1550
- Acronym
- SLN
- Status last verified
- Nov 2024
- First submitted
- 17 Nov 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be shared except personal privacy related ones
Publications
ASGE Technology Committee; Kethu SR, Banerjee S, Desilets D, Diehl DL, Farraye FA, Kaul V, Kwon RS, Mamula P, Pedrosa MC, Rodriguez SA, Wong Kee Song LM, Tierney WM. Endoscopic tattooing. Gastrointest Endosc. 2010 Oct;72(4):681-5. doi: 10.1016/j.gie.2010.06.020.
PubMed 20883844Sun W, Chen X, Fu S, Huang X. Feasibility of Sentinel Lymph Node Mapping With Carbon Nanoparticles in Cervical Cancer: A Retrospective Study. Cancer Control. 2023 Jan-Dec;30:10732748231195716. doi: 10.1177/10732748231195716.
PubMed 37624147Holloway RW, Abu-Rustum NR, Backes FJ, Boggess JF, Gotlieb WH, Jeffrey Lowery W, Rossi EC, Tanner EJ, Wolsky RJ. Sentinel lymph node mapping and staging in endometrial cancer: A Society of Gynecologic Oncology literature review with consensus recommendations. Gynecol Oncol. 2017 Aug;146(2):405-415. doi: 10.1016/j.ygyno.2017.05.027. Epub 2017 May 28.
PubMed 28566221Margioula-Siarkou C, Almperis A, Gullo G, Almperi EA, Margioula-Siarkou G, Nixarlidou E, Mponiou K, Papakotoulas P, Sardeli C, Guyon F, Dinas K, Petousis S. Sentinel Lymph Node Staging in Early-Stage Cervical Cancer: A Comprehensive Review. J Clin Med. 2023 Dec 20;13(1):27. doi: 10.3390/jcm13010027.
PubMed 38202034
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Charcoal Carbon Dye in Sentinel Lymph Node (SLN) Mapping in Early Stage Cervical Cancer
- ClinicalTrials.gov ID
- NCT06697054
- Acronym / sponsor ID
- SLN / 2024/1550
- Conditions
- Cervical Cancers
- Keywords
- cervical cancer, indocyanine green, ICG, carbon dye, sentinel lymph node
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 12 May 2024 (actual)
- Primary completion
- 12 May 2026 (estimated)
- Study completion
- 12 Jun 2026 (estimated)
- First posted
- 20 Nov 2024 (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.
The aim of the present study is to compare the efficacy of charcoal carbon dye (CCD) in sentinel lymph node mapping compared to indocyanine green (ICG) mapping regarding detection rates, sensitivity, specificity, negative and positive predictive values in early stage cervical cancers (IA2 - IB2).
Detailed description
Cervical cancer continues to be a global health problem despite the advances in prevention, screening and treatment in preinvasive stages. Although radiotherapy is the mainstay of treatment across all stages, surgery with radical and non-radical hysterectomy with pelvic lymph node evaluation is preferred in younger women with early stage cervical cancer who wants to preserve ovarian and sexual functions that may otherwise be hampered by radiotherapy. Lymph node evaluation is critical during and/or after surgery (usually before hysterectomy) and offered by global institutions since hysterectomy during surgery is abandoned in case of a metastasis in pelvic / paraaortic lymph node(s) and/or necessities primary chemoradiation or adjuvant therapy as a therapeutic modality.
During the last 10-15 years surgical sentinel lymph node (SLN) evaluation instead of complete dissection pelvic / paraaortic lymphadenectomy has gained popularity with equal success, especially in cervical tumors with less than 2-4 cm in diameter. Besides, all other advantages of sentinel lymph node evaluation is alike the advantages of other sentinel lymph node evaluation in various other cancers (vulva, breast, endometrial cancers..) with less morbidity such as less vascular injury, lymphedema, lymphocyst formation and etc. Various tracers have been used for sentinel lymph node detection in cervical cancer surgery but indocyanine green (ICG) use has surpassed other SLN mapping tracers and methods and it is the most common agent for detecting SLN in gynecologic oncology. However, it needs a fairly expensive equipment and expertise either by laparoscopy or laparotomy. In the present study, investigators are planning to use charcoal carbon dye (CCD) in addition to ICG as their usual method for SLN mapping. CCD is commonly used by general surgeons for marking of colon during preoperative colonoscopy to delineate the point of resection in surgery for colorectal resection. It is cheap and does not require special equipment and easy to learn. CCD is planned to be given just as the same as giving ICG to the cervix with 1 cc injection at each site of external os (3 and 9 o'clock position, 0.5 cc given to submucosal area and 0.5 given stroma of cervix). 20 minutes following the injection of both agents, laparoscopic dissection of retroperitoneal area will be performed to detect pelvic and paraaortic sentinel lymph nodes (up to inferior mesenteric artery) with ICG and/or CCD.
The aim of the present study is to compare the efficacy of CCD in sentinel lymph node mapping compared to ICG mapping regarding detection rates, sensitivity, specificity, negative and positive predictive values in early stage cervical cancers (IA2 - IB2).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single arm interventional study aiming at the comparison of the effectiveness of detection for sentinel lymph node biopsy using charcoal carbon dye compared to classic indocyanine (ICG) tracer in early stage cervical cancer. Sentinel lymph node detection rates of both tracers in pelvic, obturator and inframesenteric para-aortic whteher bilateral/ unilateral) will be compared in addition to sensitivity, specificity and negative and positive predictive value.
| Arm | Type | Receives |
|---|---|---|
| Two different tracers as a sentinel lymph node agent will be compared in early cervical cancer | Experimental | Diagnostic Test: Sentinel node biopsy with either ICG or carbon dye injection to cervixTwo different tracers, one charcoal carbon dye and other indocyanine used as sentinel lymph node agent will be compared in early cervical cancer in terms of detection rates, sensitivity, specificity, negative and positive predictive value. Both tracers will be used in the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 1.Pervious radiotherapy 2.Age less than 18 3.Previous pelvic retroperitoneal surgery
- -
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 node biopsy with either ICG or carbon dye injection to cervixEither laparatomy or laparoscopy wil be performed to detect sentinel node stained with either ICG or carbon dye injected to cervix. A hemipelvis in which a sentinel is not found will be subjected to full lymphadenectomy. | Diagnostic test | Two different tracers as a sentinel lymph node agent will be compared in early cervical cancer |
Primary outcome
Detection rate of sentinel lymph node(s)
Time frame: Two years
Detection rate of sentinel lymph node(s) either by carbon dye or ICG unilaterally or bilaterally will be recorded and compared.
Specifity of sentinel lymph node mapping by carbon dye or ICG
Time frame: Two years
Sensitivities of both tracers for malignancy will be compared to each other
Sensitivity of both tracers will be compared.
Time frame: Two years
Sensitivity of both tracers will be compared for malignant metastasis
Sensitivity of both tracers will be compared.
Time frame: Two years
Positive and negative predictive values of both tracers for malignant metastasis will be compared.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Background: PubMed 20883844ASGE Technology Committee; Kethu SR, Banerjee S, Desilets D, Diehl DL, Farraye FA, Kaul V, Kwon RS, Mamula P, Pedrosa MC, Rodriguez SA, Wong Kee Song LM, Tierney WM. Endoscopic tattooing. Gastrointest Endosc. 2010 Oct;72(4):681-5. doi: 10.1016/j.gie.2010.06.020.
- Background: PubMed 37624147Sun W, Chen X, Fu S, Huang X. Feasibility of Sentinel Lymph Node Mapping With Carbon Nanoparticles in Cervical Cancer: A Retrospective Study. Cancer Control. 2023 Jan-Dec;30:10732748231195716. doi: 10.1177/10732748231195716.
- Background: PubMed 28566221Holloway RW, Abu-Rustum NR, Backes FJ, Boggess JF, Gotlieb WH, Jeffrey Lowery W, Rossi EC, Tanner EJ, Wolsky RJ. Sentinel lymph node mapping and staging in endometrial cancer: A Society of Gynecologic Oncology literature review with consensus recommendations. Gynecol Oncol. 2017 Aug;146(2):405-415. doi: 10.1016/j.ygyno.2017.05.027. Epub 2017 May 28.
- Background: PubMed 38202034Margioula-Siarkou C, Almperis A, Gullo G, Almperi EA, Margioula-Siarkou G, Nixarlidou E, Mponiou K, Papakotoulas P, Sardeli C, Guyon F, Dinas K, Petousis S. Sentinel Lymph Node Staging in Early-Stage Cervical Cancer: A Comprehensive Review. J Clin Med. 2023 Dec 20;13(1):27. doi: 10.3390/jcm13010027.
- Individual participant dataSharing planned: Yes. All data will be shared except personal privacy related ones
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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.
Yavuz Salihoglu, Prof. Dr. study director
ISTANBUL UNİVERSİTY MED FAC DEPT. OF OBSTET AND GYNECOL. DIVISION OF GYNECOLOGİC 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 node biopsy with either ICG or carbon dye injection to cervix in people with Cervical Cancers, run by Istanbul University at 1 site in Turkey (Türkiye).
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 0 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 20 Nov 2024. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
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?
Detection rate of sentinel lymph node(s) (time frame: Two years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06697054, which also lists 4 linked publications.
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 20 Nov 2024.