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Robot and 3D imaging join forces to spot lung cancer in HIV patients

NCT ID NCT07663656

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

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  1. The official record

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