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A Randomized control study and Meta-analysis comparing PET, CT and MRI scans for initial assessment of oral cancers

Positron Emission Tomography (PET) with Contrast Enhanced Computerized Tomography (CECT) versus CECT versus Magnetic Resonance Imaging (MRI) for Initial Evaluation of Oral Cancers â?? A Three Parallel Arm Randomized Control Trial and Meta-Analysis : ORCID - M Trial - ORCID - M Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/12/038989
Enrollment
93
Registered
2021-12-28
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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

Conditions

Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Interventions

Intervention1: PETCECT: POSITRON EMISSION COMPUTERIZED TOMOGRAHY AS AN INITIAL ASSESSMENT FOR ORAL CANCER. PATIENTS RANDOMIZED INTO THIS ARM WILL UNDERGO PET CECT AS THE RADIOLOGICAL ASSESSMENT FOR

Sponsors

ALL INDIA INSTITUTE OF MEDICAL SCIENCES RAIPUR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.1.1 Histologically proven, treatment naïve oral cavity cancers. 1.1.2 Oral cancers amenable for a surgery as a primary treatment modality. 1.1.3 Aged between 18 to 75 years. 1.1.4 ECOG status 0 to 2

Exclusion criteria

Exclusion criteria: 1.2.1 Neoadjuvant chemotherapy prior to surgery 1.2.2 Previous oncological treatment 1.2.3 Recurrent or second primary tumours 1.2.4 ASA more than III 1.2.5 PETCECT as an initial investigation of choice for advanced stage disease as deemed necessary by the tumour board.

Design outcomes

Primary

MeasureTime frame
To determine sensitivity, specificity, negative predictive value, and positive predictive value of PET CECT, CECT and MRI for determining the primary tumour, and nodal metastasis (Part 1 and Part 2)Timepoint: AT BASELINE

Secondary

MeasureTime frame
1. To determine the cut-off maximum Standard Uptake Value (SUVmax) for neck nodal metastasis. (Part 1) 2. To determine the cut-off maximum Standard Uptake Value (SUVmax) for primary tumour margin. (Part 2) 3. To create a real world high quality evidence, by comparing the exiting literature as a meta-analysis with our results (Part 2 of study)Timepoint: AT BASELINE

Countries

India

Contacts

Public ContactKARTHIK NAGARAJA RAO

ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RAIPUR

directoroffice@aiimsraipur.edu.in8861373839

Outcome results

None listed

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