Robot and 3D imaging join forces to spot lung cancer in HIV patients
NCT ID NCT07663656
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new robotic bronchoscopy system that uses real-time 3D imaging to help doctors biopsy lung nodules in people with HIV. The goal is to see if this robot-guided approach is more accurate and safer than current navigation methods. One hundred participants will be randomly assigned to either the robot or a standard electromagnetic navigation system. If the biopsy shows cancer and it is safe, doctors may also treat the nodule with freezing (cryoablation) during the same procedure.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Robotic bronchoscopy with CBCT-guided multimodal image fusion and targeted cryobiopsy
- What this could lead to
- If successful, this could provide a more accurate and safer way to diagnose lung nodules in people with HIV, potentially allowing same-session treatment for early-stage lung cancer.
- What could go wrong
- This is an early-stage study with only 100 participants, so results may not apply to everyone. The robotic system is complex and may not always reach the nodule, requiring alternative procedures.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Confirmed diagnosis of HIV infection; on stable antiretroviral therapy (ART) for ≥6 months with plasma HIV viral load \<50 copies/mL. 2. Presence of at least one pulmonary nodule ≤3 cm in maximum diameter on thin-section CT; radiological features suggestive of malignancy (e.g., part-solid or solid nodule with spiculation, lobulation, or vessel convergence) with estimated pretest probability of malignancy ≥50%. 3. Age 18-70 years. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 5. Life expectancy ≥6 months. 6. Voluntary written informed consent obtained prior to any study procedure; willingness and ability to comply with scheduled visits, procedures, and follow-up requirements. Exclusion Criteria: 1. Active pulmonary tuberculosis or Pneumocystis jirovecii pneumonia requiring acute treatment at the time of screening. 2. Coagulation disorder: International Normalized Ratio (INR) \>1.5 or platelet count \<50 × 10\^9/L. 3. Prior definitive treatment for the target pulmonary nodule (e.g., surgical resection, radiotherapy, ablation, or systemic anti-tumor therapy). 4. Unstable ART status: not on continuous ART or HIV viral load ≥50 copies/mL within 3 months prior to enrollment. 5. Target lesion already diagnosed definitively by previous percutaneous biopsy or surgical pathology. 6. Severe cardiopulmonary dysfunction: * Forced Expiratory Volume in 1 second (FEV1) \<50% predicted; or * New York Heart Association (NYHA) Class III-IV heart failure. 7. Pregnancy or breastfeeding. 8. Participation in another interventional clinical trial within the past 3 months. 9. Inability to complete follow-up (e.g., no fixed residence, unstable contact information). 10. Any other condition that, in the investigator's judgment, would make the participant unsuitable for enrollment or pose unacceptable risk (including significant airway abnormality preventing safe navigation).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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