Lung DiseasesNCT06923098
PET/CT GUIDED BIOPSY VERSUS CT GUIDED BIOPSY IN EVALUATION OF SUSPECTED LUNG NEOPLASMS
A study testing PET-CT guided biopsy and CT guided biopsy in people with Lung Diseases, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
Trial summary
Percutaneous CT guided biopsy is a well-established, standard sampling technique for suspected neoplastic lesions located in peripheral region in lung parenchyma. Inconclusive results on CT guided biopsy is substantially higher in large lung lesions which are prone to cause peripheral pneumonia, atelectasis and even… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases
- What is being tested?
- PET-CT guided biopsy and CT guided biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jul 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 18 years
- INR \< 1.2 and platelet counts \> 80,000/mm3
- CT thorax with lung lesion more than 10 mm.
- Accessible lesions for CT-guided biopsy.
Who cannot join
- Participants with pre-existing bleeding diathesis like hemophilia, coagulopathy defined by -INR ≥1.2 and Platelet counts ≤ 80,000/mm3
- Participants who refuse to provide consent
- Signs of hypoperfusion like hypotension, cyanosis etc.
- Presence of hypoxemia with SpO2 < 94 %- measured in a pulse oximeter)
- Pregnant/Lactating female subjects
- Non-cooperative subjects
- Lesions that are inaccessible (decision made on pre-biopsy planning)
- Serum creatinine level more than 2mg/dl.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
All India Institute of Medical Sciences, Bhubaneswar
Bhubaneswar, Odisha, 751019
Dr Girish Kumar Parida, MD, +91 9968856817, grissh135@gmail.com
About this study
Percutaneous CT guided biopsy is a well-established, standard sampling technique for suspected neoplastic lesions located in peripheral region in lung parenchyma. Inconclusive results on CT guided biopsy is substantially higher in large lung lesions which are prone to cause peripheral pneumonia, atelectasis and even regional necrosis, which are hard to be distinguished from tumor on CT images.
Functional imaging guided biopsy like PET/CT guided biopsy identifies areas of highest concentration of neoplastic cells and provides accurate results. Only a few studies have been done regarding PET/CT guided biopsy and studies omparing PET/CT guided and CT guided percutaneous transthoracic lung biopsy are very few and this study would be a randomized trial comparing these diagnostic modalities in terms of diagnostic yield, diagnostic accuracy of sample and complications.
- Conditions
- Lung Diseases
- Being tested
- PET-CT guided biopsy, CT guided biopsy
- Keywords
- CT guided biopsy, PET-CT guided biopsy, Lung lesions
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-CT guided biopsyProcedure or surgery
PET-CT guided biopsy of lung lesions
CT guided biopsyProcedure or surgery
CT guided biopsy of lung lesions
| Study group | Role | What they receive |
|---|---|---|
| CT guided biopsy | Active comparator | Not described Receives: Procedure: CT guided biopsy |
| PET-CT guided biopsy | Experimental | Not described Receives: Procedure: PET-CT guided biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inconclusive pathology findings
Comparing the proportion of inconclusive pathology reports in both arms
Measured: 1 month
Secondary outcomes (1)
Incidence of pneumothorax and hemoptysis
Incidence of pneumothorax and hemoptysis in both arms
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start1 Jul 2023
- Primary completionJul 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Girish Kumar Parida, All India Institute of Medical Sciences, Bhubaneswar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923098
- Sponsor's protocol ID
- IEC/AIIMS BBSR/PG Thesis/2023-
- Status last verified
- Apr 2025
- First submitted
- 4 Apr 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET/CT GUIDED BIOPSY VERSUS CT GUIDED BIOPSY IN EVALUATION OF SUSPECTED LUNG NEOPLASMS
- ClinicalTrials.gov ID
- NCT06923098
- Acronym / sponsor ID
- IEC/AIIMS BBSR/PG Thesis/2023-
- Conditions
- Lung Diseases
- Keywords
- CT guided biopsy, PET-CT guided biopsy, Lung lesions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- All India Institute of Medical Sciences, BhubaneswarUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Percutaneous CT guided biopsy is a well-established, standard sampling technique for suspected neoplastic lesions located in peripheral region in lung parenchyma. Inconclusive results on CT guided biopsy is substantially higher in large lung lesions which are prone to cause peripheral pneumonia, atelectasis and even regional necrosis, which are hard to be distinguished from tumor on CT images.
Functional imaging guided biopsy like PET/CT guided biopsy identifies areas of highest concentration of neoplastic cells and provides accurate results. Only a few studies have been done regarding PET/CT guided biopsy and studies omparing PET/CT guided and CT guided percutaneous transthoracic lung biopsy are very few and this study would be a randomized trial comparing these diagnostic modalities in terms of diagnostic yield, diagnostic accuracy of sample and complications.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT guided biopsy | Active comparator | Procedure: CT guided biopsy |
| PET-CT guided biopsy | Experimental | Procedure: PET-CT guided biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age above 18 years
- INR \< 1.2 and platelet counts \> 80,000/mm3
- CT thorax with lung lesion more than 10 mm.
- Accessible lesions for CT-guided biopsy.
Key exclusion criteria (8 listed)
- Participants with pre-existing bleeding diathesis like hemophilia, coagulopathy defined by -INR ≥1.2 and Platelet counts ≤ 80,000/mm3
- Participants who refuse to provide consent
- Signs of hypoperfusion like hypotension, cyanosis etc.
- Presence of hypoxemia with SpO2 < 94 %- measured in a pulse oximeter)
- Pregnant/Lactating female subjects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET-CT guided biopsyPET-CT guided biopsy of lung lesions | Procedure or surgery | PET-CT guided biopsy |
| CT guided biopsyCT guided biopsy of lung lesions | Procedure or surgery | CT guided biopsy |
Primary outcome
Inconclusive pathology findings
Time frame: 1 month
Comparing the proportion of inconclusive pathology reports in both arms
1 secondary outcome
Incidence of pneumothorax and hemoptysis
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
All India Institute of Medical Sciences, Bhubaneswar
Bhubaneswar, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET-CT guided biopsy and CT guided biopsy in people with Lung Diseases, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inconclusive pathology findings (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.