Medical diagnostic device for cancer margin detectio

Not Applicable

• Conditions: Health Condition 1: C509- Malignant neoplasm of breast of unspecified siteHealth Condition 2: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx

• Registration Number: CTRI/2023/04/051885
• Lead Sponsor: Dr Jyotirmayee Dash

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

For Inclusion, an individual must meet all of the following criteria.

Inability to meet all inclusion criteria for a cohort will lead to exclusion.

1. Adult males and females, aged 18 years and above

2. Provision of Informed Consent

3. Willing and able to participate in the study and provide tissue samples as per availability and feasibility.

4. No co-morbidities which could impair study participation or sample collection,

5. Female participants: neither pregnant, nor lactating

6. For Study A (Known Cancer Cases)

(6a). Diagnosed with any malignancy as per current appropriate Standard of Care approach.

(6b). Therapy Naïve as well as received prior anticancer treatments.

7. For Study B (Known Benign Cases)

(7a). No prior diagnosis of any cancer.

(7b). Confirmed diagnosis of benign (non-cancerous / non-malignant) conditions as per relevant Standard of Care diagnostic work-up.

Exclusion Criteria

For Exclusion, an individual may meet any of the following criteria.

Meeting even one exclusion criteria will lead to exclusion.

1. Age less than 18 years,

2. Inability to provide Informed Consent,

3. Failure to meet general or study-specific Inclusion Criteria

4. Pregant and lactating female participants.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cancer margin detection using Terahertz and Fluorescence device with higher sensitivity and specificity. The device can differentiate between benign and malignant tissues.Timepoint: 2 years

Secondary Outcome Measures

Name	Time	Method
To determine the capability of the Terahertz device as a complementary technique to histopathology.Timepoint: Every 6 months