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Testing of a new device using infrared radiation to detect viable cancer in the cervix

ViablE Residual Disease at Intracavitary brachytherapy after Chem-radio Therapy I Carcinoma Cervix:Detection, Characterization and prognostic Significance(VERDICT) Amplification determination of diagnostic accuracy and prognostic utility HINA - VERDICT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/092661
Enrollment
54
Registered
2025-08-08
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C538- Malignant neoplasm of overlappingsites of cervix uteri

Interventions

Intervention1: Far Infrared Imaging: Far infrared imaging at the time of brachytherapy for identification of residual disease. This imaging will be used to determine the presence of viable residual di

Sponsors

Department of Biotechnology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Biopsy proven carcinoma cervix patients who are planned for treatment with definitive concurrent chemoradiation using weekly Cisplatin. Histology: Squamous Cell Carcinoma, Adenosquamous carcinoma, Adenocarcinoma FIGO 2018 stage I - IIIC. Have pretreatment biopsy taken at Tata Medical Center or reviewed at Tata Medical Center.

Exclusion criteria

Exclusion criteria: Presence of any bleeding disorder Presence of idiopathic thrombocytopenic purpura or any other platelet disorder HIV Positivity Unavailable for follow up at Tata Medical Center. Patients who have undergone chemoradiation / radiation therapy outside. Presence of cochlear implant Presence of non-MRI safe implants and pacemakers Planned for palliative intent radiotherapy Stage IV patients Patients treated with neoadjuvant chemotherapy Prior history of radiation therapy to the pelvis

Design outcomes

Primary

MeasureTime frame
Sensitivity and Sepecificity of the device.Timepoint: Sensitivity and Sepecificity of the device.

Secondary

MeasureTime frame
To determine the prognostic impact of the volume of residual abnormality in MRI (GTres) on: The clinical complete response rate on MRI at 3 months post-treatment. Timepoint: 3 months;Quantification of Tumor Infiltrating Lymphocytes in the biopsy specimens and PD-L1 expression in the tumor and immune cells. Timepoint: At brachytherapy;Determine the prognostic impact of the above parameters on disease-free survivalTimepoint: 3 years

Countries

India

Contacts

Public ContactTapesh Bhattacharyya

Tata Medical Center

drsantam@gmail.com9831188676

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026