A randomized controlled trial of low dose computed tomography versus ultra-low dose computed tomography for lung cancer screening in high-risk individuals

A randomized controlled trial of low-dose computed tomography versus ultra-low dose computed tomography for lung cancer screening in high-risk individuals. - nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/12/078358

Enrollment

164

Registered

2024-12-20

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Health Condition 1: J439- Emphysema, unspecified

Interventions

Intervention1: Ultra low dose computed tomography: 1 mSv, 20-40 mAs, 60-80 kVp. Each scan will be performed once at baseline in the recruited participants. Depending on the scan result, participant ma

Eligibility

Inclusion criteria

Inclusion criteria: 1. Individuals aged =50 years with =20 pack-year history of smoking (or smoking index =400)

Exclusion criteria

Exclusion criteria: 1. Symptomatic structural lung disease other than COPD (e.g., bronchiectasis, chronic pulmonary aspergillosis, pulmonary fibrosis) 2. Severe comorbid condition which is likely to limit the survival of the patient in the opinion of the investigator (e.g., advanced lung disease, cardiovascular disease, chronic kidney disease, chronic liver disease) 3. Clinical suspicion of lung cancer (e.g., symptoms [hemoptysis, hoarseness, chest pain], signs [clubbing, lymphadenopathy], or abnormal chest radiograph [mediastinal widening, lung nodule or mass, collapse, or pleural effusion] suggestive of malignancy). 4. Conditions which may interfere interpretation of CT (e.g., metallic implants on chest wall, cardiac pacemakers) 5. Treatment for any other cancer in the last 5 years 6. Pulmonary infection (for which treatment with antimicrobials is indicated) which is active at present or was recent (within the last 3 months) 7. Patients who have underwent CT chest within the last 12 months 8. Negative consent

Design outcomes

Primary

Measure	Time frame
Screen positivity rate with LDCT and ULDCT screeningTimepoint: 18 months from the start of trial	—

Secondary

Measure	Time frame
1. Mean radiation dose with LDCT and ULDCT 2. Lung cancer detection rate with LDCT and ULDCT 3. Proportion of patients requiring additional procedures (imaging/invasive procedures) in both groups 4. Proportion of patients developing complications due to additional procedures in both groups 5. Proportion of patients who quit/re-initiated smoking after inclusion in studyTimepoint: 18 months from the start of trial	—

Measure

Time frame

1. Mean radiation dose with LDCT and ULDCT 2. Lung cancer detection rate with LDCT and ULDCT 3. Proportion of patients requiring additional procedures (imaging/invasive procedures) in both groups 4. Proportion of patients developing complications due to additional procedures in both groups 5. Proportion of patients who quit/re-initiated smoking after inclusion in studyTimepoint: 18 months from the start of trial

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Countries

India

Contacts

Public ContactVikram Damaraju

All India Institute of Medical Sciences, Mangalagiri, India

damarajuvikram@gmail.com9501482884

Outcome results

None listed

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