NCT00070317

Brief Summary

This clinical trial is studying how well lymph node mapping and sentinel lymph node identification work in finding lymph node metastases in patients with stage IB1 cervical cancer. Diagnostic procedures, such as lymph node mapping and sentinel lymph node identification, performed before and during surgery, may improve the ability to detect lymph node metastases in patients who have cervical cancer.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2003

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2004

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

October 3, 2017

Completed
Last Updated

November 6, 2017

Status Verified

June 1, 2015

Enrollment Period

8.6 years

First QC Date

October 3, 2003

Results QC Date

September 8, 2017

Last Update Submit

October 3, 2017

Conditions

Cervical AdenocarcinomaCervical Adenosquamous CarcinomaCervical Squamous Cell CarcinomaStage I Cervical Cancer

Outcome Measures

Primary Outcomes (2)

  • Sensitivity

    Sensitivity is defined as the proportion of patients who test as positive sentinel node among the patients who have lymph node metastases.

    At the time of surgery

  • False Negative Predictive Value (FNPV)

    The proportion of patients with FNPV among patients who tests as negative sentinel node, where FNPV is defined as a person who tests as negative sentinel node but who actually has lymph node metastases

    At the time of Surgery

Study Arms (1)

Diagnostic

EXPERIMENTAL

Patients receive radiolabeled technetium Tc 99m sulfur colloid injected around the tumor 6 hours prior to or after induction of anesthesia right before surgery. Patients then undergo radical hysterectomy and complete pelvic and low para-aortic lymphadenectomy. Intraoperatively, patients undergo lymphatic mapping and sentinel lymph node identification using isosulfan blue or methylene blue injected at 4 locations in the cervix and a hand-held gamma counter.

Drug: Isosulfan BlueProcedure: Lymph Node MappingProcedure: LymphangiographyDrug: Methylene BlueProcedure: Radionuclide ImagingProcedure: Sentinel Lymph Node BiopsyRadiation: Technetium Tc-99m Sulfur ColloidProcedure: Therapeutic Conventional Surgery

Interventions

Isosulfan BlueDRUG

Undergo lymphangiography using isosulfan blue or methylene blue

Also known as: Lymphazurin, N-[4-[(4-(diethylamino)phenyl)(2,5-disulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl-ethanaminium hydroxide
Diagnostic
Lymph Node MappingPROCEDURE

Undergo lymphatic mapping

Also known as: lymphatic mapping
Diagnostic
LymphangiographyPROCEDURE

Undergo lymphangiography using isosulfan blue or methylene blue

Also known as: Lymphography
Diagnostic
Methylene BlueDRUG

Undergo lymphangiography using isosulfan blue or methylene blue

Also known as: Azul de Metileno, Azul Metile, Blu di Metilene, CI Basic Blue 9, CI-52015, Collubleu, Colour Index No. 52015, Desmoidpillen, Methylenum Caeruleum, Methylthioninii Chloridum, Methylthioninium Chloride, Schultz No. 1038, Tetramethylthionine Chloride Trihydrate, Urolene Blue, Vitableu
Diagnostic
Radionuclide ImagingPROCEDURE

Undergo radionuclide imaging with technetium Tc 99m sulfur colloid

Also known as: nuclear medicine scan, radioimaging, Radionuclide Scanning, Scan, SCINTIGRAPHY
Diagnostic
Sentinel Lymph Node BiopsyPROCEDURE

Undergo complete pelvic and low para-aortic lymphadenectomy

Also known as: Sentinel Node Biopsy, Sentinel node biopsy alone, SLNB, SNB
Diagnostic
Technetium Tc-99m Sulfur ColloidRADIATION

Undergo radionuclide imaging with technetium Tc 99m sulfur colloid

Also known as: Tc 99m Sulfur Colloid, Tc-99m SC, Technetium Tc 99m Sulfur Colloid
Diagnostic
Therapeutic Conventional SurgeryPROCEDURE

Undergo radical hysterectomy

Diagnostic

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of carcinoma of the cervix of 1 of the following cellular types:
  • Squamous cell carcinoma
  • Adenocarcinoma
  • Adenosquamous cell carcinoma
  • Stage IB1 disease (no greater than 4 cm)
  • No unequivocal evidence of metastases
  • Adequate surgical candidate
  • No known allergy to triphenylmethane compounds
  • No prior pelvic irradiation
  • No prior retroperitoneal surgery
  • More than 4 weeks since prior cold knife or loop electrosurgical excision procedure (LEEP) cone biopsy
  • Prior cone biopsy allowed provided current disease is stage IB1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gynecologic Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

iso-sulfan bluesulfan blueMethylene BlueSentinel Lymph Node BiopsyTechnetium Tc 99m Sulfur Colloid

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

PhenothiazinesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsBiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeLymph Node ExcisionInvestigative TechniquesInorganic ChemicalsTechnetium Compounds

Results Point of Contact

Title
Linda Gedeon for Wei Deng, PhD.
Organization
NRG Oncology
lgedeon@gogstats.org
716-845-1169

Study Officials

  • Charles Levenback

    Gynecologic Oncology Group

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2003

First Posted

October 7, 2003

Study Start

June 1, 2004

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

November 6, 2017

Results First Posted

October 3, 2017

Record last verified: 2015-06

Locations

US(1)