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Clinical Trials/CTRI/2023/03/051086
CTRI/2023/03/051086
Recruiting
Phase 2

Evaluation of Indocyanine Green (ICG) and Handheld Fluorescence Imager in the Management of Early Stage Gynecological Cancers

Indian Council of Medical Research, New Delhi0 sites0 target enrollmentTBD
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Indian Council of Medical Research, New Delhi
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Indian Council of Medical Research, New Delhi

Eligibility Criteria

Inclusion Criteria

  • •1\. Biopsy proven in cases of endometrial, cervical \& vulvar cancers
  • •2\. Uterine confined malignancy with no evidence of metastasis on imaging and no apparent extrauterine disease at exploration
  • •3\. Stage 1 cervical cancer with tumor size less than 4 cm
  • •4\. Patients of carcinoma vulva with negative clinical groin examination and/or imaging and a primary unifocal vulvar tumor of less than 4 cm
  • •5\. Patients with stage I and II epithelial ovarian cancers
  • •6\. Patients with suspicious ovarian masses planned for hysterectomy and or salpingo\-oophorectomy

Exclusion Criteria

  • •1\. Signs of malignant spread to the abdominal cavity on preoperative imaging
  • •2\. Patients with allergies to ICG
  • •3\. Prior history of surgery for the genital malignancy
  • •4\. Previous lymphadenectomy or lymph node sampling in the pelvic or para\-aortic region
  • •5\. Suspicious lymph nodal involvement on imaging
  • •6\. Women who have received chemotherapy and/or radiation
  • •7\. Recurrent malignancy
  • •8\. Pregnant or lactating patistudy
  • •9\. Not willing to participate in the study

Outcomes

Primary Outcomes

Not specified

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