Vulval CancerIFLNDNCT06694116
Charcoal Carbon Black Dye Use in Sentinel Lymph Node Mapping in Early Stage Vulvar Cancer
A study testing sentinel lymph node biopsy using carbon dye in people with Vulval Cancer and Sentinel Lymph Node Detection, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the detection rate, sensitivity and specifity of charcoal carbon black dye as a sentinel lymph node tracer in inguinofemoral lymph node(s) in early stage vulvar cancer Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulval Cancer, Sentinel Lymph Node Detection
- What is being tested?
- sentinel lymph node biopsy using carbon dye
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2024to Nov 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
Inclusion Criteria: Women with primary early stage vulvar cancer (Figo stage I and II) who will be operated with vulvar and inguinofemoral dissection -
Exclusion Criteria: Women less than 18 years of age or who declines 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
About this study
The aim of this study is to investigate the detection rate, sensitivity and specifity of charcoal carbon black dye as a sentinel lymph node tracer in inguinofemoral lymph node(s) in early stage vulvar cancer
Read the detailed description
Vulvar cancer is a rare malignancy constituting approximately only 4% of all gynaecological malignancies. Treatment depends on histopathology and stage with surgery being the primary treatment modality in early stages with or without adjuvant radiotherapy depending on tumor margin status and involvement of inguinofemoral lymph nodes. Bilateral or unilateral surgical evaluation of inguinofemoral lymph nodal basin is an important part of the surgical procedure in early stage disease besides vulvar surgery since metastatic involvement dramatically changes stage, adjuvant treatment and surveillance. The usual method for surgical evaluation of inguinofemoral lymph nodes is full inguinofemoral lymph node dissection (IFLND). However, IFLND is highly related to complications such as lymphedema, incisional detachment, lymphocyst formation, lymphangitis, vessel injury and deep venous thrombosis. Over the last 10-15 years sentinel lymph node biopsy of inguinofemoral lymph nodes became a well-accepted form of surgical evaluation procedure instead of IFLND.
The present guidelines offer sentinel lymph node biopsy using various tracers and dyes used alone or in combination (either a blue dye or indocyanine green -ICG (indocyanine green) - is offered in addition to radiocolloid tracer). However, radiocolloid and ICG tracers requires expensive equipment and cumbersome procedures. On the contrary, sterile charcoal carbon dye is inexpensive and does not necessitate any further equipment to be detected. It is actually used to mark the point of resection of colon during colorectal surgery by general surgeons which is injected to the colonic mucosa preoperatively by colonoscopy.
The aim of the present study is to investigate the sensitivity, specificity, negative predictive value and positive predictive value of using charcoal carbon dye as a sentinel tracer in IFLN basin. Early-stage primary vulvar tumors less than 4 cm with any histology but without any clinically or radiographically detectable inguinofemoral lymph nodes will be included into study. Peritumoral four quadrant injections of carbon dye each 0.5 cc or two injections of 3 and 9 o'clock each 1 cc will be given. Following a 20 min interval inguinofemoral area will be dissected and full lymphadenectomy will be performed irrespective of sentinel lymph node recovery since bilateral or unilateral full inguinofemoral lymph node dissection is done in the department of the study so far. Detection rate and other parameters (sensitivity, specificity and etc.) will be compared to results of pathologic evaluation of full IFLND.
Investigators are currently two ongoing studies using charcoal carbon dye as a sentinel tracer to investigate its effectiveness compared to ICG (one in endometrial cancer and the other in ovarian cancer). Both studies are registered to ClinicalTrials.gov (NCT06163963 and NCT05927818). This will be the third of the study series using charcoal carbon dye as sentinel lymph node mapping method in gynecologic cancers (Forth one will be registered in ClinicalTrials.gov shortly in cervical cancers compared to ICG).
- Conditions
- Vulval Cancer, Sentinel Lymph Node Detection
- Being tested
- sentinel lymph node biopsy using carbon dye
- Keywords
- vulvar cancer, observatinal study, charcoal carbon dye
- Medical subject headings
- Vulvar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sentinel lymph node biopsy using carbon dyeDiagnostic test
Sterile Charcoal carbon dye peritumoral injection will be performed around vulvar tumor and inguinofemoral lymph node dissection will be done 20 min later (unilateral or bilateral)
| Study group | Role | What they receive |
|---|---|---|
| Single arm study using carbon dye as a sentinel lymph node agent in early vulvar cancer | Experimental | Single arm study using carbon dye as a sentinel lymph node agent in early vulvar cancer. Sterile charcoal carbon dye will be injected around vulvar tumor which will be searched in IFLND. No other arms. Receives: Diagnostic Test: sentinel lymph node biopsy using carbon dye |
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 of sentinel lymph node for both unilateral or bilateral inguinofemoral region (in percentages). (For instance: In what percentage a unilateral or bilateral sentinel lymph node stained with carbon dye - either negative or positive - is detected?)
Measured: Two years
Sensitivity of sentinel lymph node mapping
Sentinel lymph nodes true positive for malignancy in percentages divided by all sentinel lymph nodes either positive or negative for malignancy which is determined by pathologic report after all full inguinofemoral lymph nodes are examined for malignancy
Measured: Two years
Specifity of sentinel lymph node mapping
Detection of true negative sentinel lymph nodes for malignancy divided by all sentinel lymph nodes either positive or negative for malignancy which is determined after all full inguinofemoral lymph nodes are examined pathologically
Measured: Two years
Negative and positive predictive values
Detection of ratio of negative and positive for malignancy with sentinel lymph nodes to negative and positive for malignancy detected by full inguinofemoral lymph node dissection respectively
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 posted19 Nov 2024
- Study start30 May 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Vulval CancerStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The aim of this single arm prospective observational and intervational study is to investigate the detection rate, sensitivity, specificity, negative predictive value and positive predictive value of using charcoal carbon dye as a sentinel tracer in IFLN basin. Early stage primary vulvar tumors less than 4 cm with any histology but without any clinically or radiographically detectable inguinofemoral lymph nodes will be included. The parameters will be compared to pathologic results obtained from full IFLND.
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT06694116
- Sponsor's protocol ID
- 2024/1551
- Acronym
- IFLND
- Status last verified
- Nov 2024
- First submitted
- 15 Nov 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes
Publications
Holloway 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 28566221ASGE 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 20883844Rychlik A, Bidzinski M, Rzepka J, Piatek S. Sentinel lymph node in vulvar cancer. Chin Clin Oncol. 2021 Apr;10(2):19. doi: 10.21037/cco-20-202. Epub 2020 Dec 11.
PubMed 33353362Penn CA, Schneiter MK, Watson CH. Sentinel Lymph Node Evaluation in Early-Stage Vulvar Cancer. Curr Treat Options Oncol. 2024 Jan;25(1):20-26. doi: 10.1007/s11864-023-01165-1. Epub 2024 Jan 3.
PubMed 38170388Pedrao PG, Guimaraes YM, Godoy LR, Possati-Resende JC, Bovo AC, Andrade CEMC, Longatto-Filho A, Dos Reis R. Management of Early-Stage Vulvar Cancer. Cancers (Basel). 2022 Aug 29;14(17):4184. doi: 10.3390/cancers14174184.
PubMed 36077719
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Charcoal Carbon Black Dye Use in Sentinel Lymph Node Mapping in Early Stage Vulvar Cancer
- ClinicalTrials.gov ID
- NCT06694116
- Acronym / sponsor ID
- IFLND / 2024/1551
- Conditions
- Vulval Cancer, Sentinel Lymph Node Detection
- Keywords
- vulvar cancer, observatinal study, charcoal carbon dye
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 30 May 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 19 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 this study is to investigate the detection rate, sensitivity and specifity of charcoal carbon black dye as a sentinel lymph node tracer in inguinofemoral lymph node(s) in early stage vulvar cancer
Detailed description
Vulvar cancer is a rare malignancy constituting approximately only 4% of all gynaecological malignancies. Treatment depends on histopathology and stage with surgery being the primary treatment modality in early stages with or without adjuvant radiotherapy depending on tumor margin status and involvement of inguinofemoral lymph nodes. Bilateral or unilateral surgical evaluation of inguinofemoral lymph nodal basin is an important part of the surgical procedure in early stage disease besides vulvar surgery since metastatic involvement dramatically changes stage, adjuvant treatment and surveillance. The usual method for surgical evaluation of inguinofemoral lymph nodes is full inguinofemoral lymph node dissection (IFLND). However, IFLND is highly related to complications such as lymphedema, incisional detachment, lymphocyst formation, lymphangitis, vessel injury and deep venous thrombosis. Over the last 10-15 years sentinel lymph node biopsy of inguinofemoral lymph nodes became a well-accepted form of surgical evaluation procedure instead of IFLND.
The present guidelines offer sentinel lymph node biopsy using various tracers and dyes used alone or in combination (either a blue dye or indocyanine green -ICG (indocyanine green) - is offered in addition to radiocolloid tracer). However, radiocolloid and ICG tracers requires expensive equipment and cumbersome procedures. On the contrary, sterile charcoal carbon dye is inexpensive and does not necessitate any further equipment to be detected. It is actually used to mark the point of resection of colon during colorectal surgery by general surgeons which is injected to the colonic mucosa preoperatively by colonoscopy.
The aim of the present study is to investigate the sensitivity, specificity, negative predictive value and positive predictive value of using charcoal carbon dye as a sentinel tracer in IFLN basin. Early-stage primary vulvar tumors less than 4 cm with any histology but without any clinically or radiographically detectable inguinofemoral lymph nodes will be included into study. Peritumoral four quadrant injections of carbon dye each 0.5 cc or two injections of 3 and 9 o'clock each 1 cc will be given. Following a 20 min interval inguinofemoral area will be dissected and full lymphadenectomy will be performed irrespective of sentinel lymph node recovery since bilateral or unilateral full inguinofemoral lymph node dissection is done in the department of the study so far. Detection rate and other parameters (sensitivity, specificity and etc.) will be compared to results of pathologic evaluation of full IFLND.
Investigators are currently two ongoing studies using charcoal carbon dye as a sentinel tracer to investigate its effectiveness compared to ICG (one in endometrial cancer and the other in ovarian cancer). Both studies are registered to ClinicalTrials.gov (NCT06163963 and NCT05927818). This will be the third of the study series using charcoal carbon dye as sentinel lymph node mapping method in gynecologic cancers (Forth one will be registered in ClinicalTrials.gov shortly in cervical cancers compared to ICG).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The aim of this single arm prospective observational and intervational study is to investigate the detection rate, sensitivity, specificity, negative predictive value and positive predictive value of using charcoal carbon dye as a sentinel tracer in IFLN basin. Early stage primary vulvar tumors less than 4 cm with any histology but without any clinically or radiographically detectable inguinofemoral lymph nodes will be included. The parameters will be compared to pathologic results obtained from full IFLND.
| Arm | Type | Receives |
|---|---|---|
| Single arm study using carbon dye as a sentinel lymph node agent in early vulvar cancer | Experimental | Diagnostic Test: sentinel lymph node biopsy using carbon dyeSingle arm study using carbon dye as a sentinel lymph node agent in early vulvar cancer. Sterile charcoal carbon dye will be injected around vulvar tumor which will be searched in IFLND. No other arms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 biopsy using carbon dyeSterile Charcoal carbon dye peritumoral injection will be performed around vulvar tumor and inguinofemoral lymph node dissection will be done 20 min later (unilateral or bilateral) | Diagnostic test | Single arm study using carbon dye as a sentinel lymph node agent in early vulvar cancer |
Primary outcome
Detection rate of sentinel lymph node(s)
Time frame: Two years
Detection of sentinel lymph node for both unilateral or bilateral inguinofemoral region (in percentages). (For instance: In what percentage a unilateral or bilateral sentinel lymph node stained with carbon dye - either negative or positive - is detected?)
Sensitivity of sentinel lymph node mapping
Time frame: Two years
Sentinel lymph nodes true positive for malignancy in percentages divided by all sentinel lymph nodes either positive or negative for malignancy which is determined by pathologic report after all full inguinofemoral lymph nodes are examined for malignancy
Specifity of sentinel lymph node mapping
Time frame: Two years
Detection of true negative sentinel lymph nodes for malignancy divided by all sentinel lymph nodes either positive or negative for malignancy which is determined after all full inguinofemoral lymph nodes are examined pathologically
Negative and positive predictive values
Time frame: Two years
Detection of ratio of negative and positive for malignancy with sentinel lymph nodes to negative and positive for malignancy detected by full inguinofemoral lymph node dissection respectively
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 19 Nov 2024.
- 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 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 33353362Rychlik A, Bidzinski M, Rzepka J, Piatek S. Sentinel lymph node in vulvar cancer. Chin Clin Oncol. 2021 Apr;10(2):19. doi: 10.21037/cco-20-202. Epub 2020 Dec 11.
- Background: PubMed 38170388Penn CA, Schneiter MK, Watson CH. Sentinel Lymph Node Evaluation in Early-Stage Vulvar Cancer. Curr Treat Options Oncol. 2024 Jan;25(1):20-26. doi: 10.1007/s11864-023-01165-1. Epub 2024 Jan 3.
- Background: PubMed 36077719Pedrao PG, Guimaraes YM, Godoy LR, Possati-Resende JC, Bovo AC, Andrade CEMC, Longatto-Filho A, Dos Reis R. Management of Early-Stage Vulvar Cancer. Cancers (Basel). 2022 Aug 29;14(17):4184. doi: 10.3390/cancers14174184.
- Individual participant dataSharing planned: Yes. Yes
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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 lymph node biopsy using carbon dye in people with Vulval Cancer and Sentinel Lymph Node Detection, 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?
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 19 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 NCT06694116, which also lists 5 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 19 Nov 2024.