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Comparing Lung Perfusion PET/CT-Guided Versus Standard Planning for Stereotactic Body Radiotherapy in Patients with Primary or Secondary Lung Tumors

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with primary lung tumors or secondary lung tumors who are scheduled to receive stereotactic body radiotherapy (SBRT). The study will use a radioactive imaging agent called [68Ga]Ga-MAA, which is a solution containing gallium and human albumin, given through an intravenous injection. This substance helps create detailed images of blood flow in the lungs using special scanning technology called PET/CT.

The purpose of this research is to compare two different approaches to planning radiation treatment. One approach uses functional lung imaging that shows blood flow patterns in the lungs, while the other uses traditional anatomical planning. The study aims to determine if using the blood flow imaging method results in fewer breathing problems or lung damage after radiation treatment.

During the study, participants will receive their prescribed radiation therapy and will have follow-up visits over one year to monitor their progress. The imaging agent will be used to create detailed pictures of their lungs before treatment and again three months after treatment. Doctors will check for any breathing difficulties or lung-related side effects throughout the study period. The maximum amount of the imaging agent used will be 200 MBq per scan, with a total of 400 MBq over two days.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial radiation treatment planning

    You will receive a lung perfusion PET/CT scan to create detailed images of your lungs. This involves receiving an intravenous injection of [68Ga]Ga-MAA solution

    The scan results will be used to plan your stereotactic body radiotherapy (SBRT) treatment for lung tumors

  2. Step 2

    Radiotherapy treatment

    You will undergo SBRT treatment sessions according to the treatment plan created from your scans

  3. Step 3

    3-month follow-up

    A medical examination will be conducted to check for any side effects in your lungs

    You will complete quality of life questionnaires

    A follow-up lung perfusion PET/CT scan will be performed

    Your progress will be evaluated for tumor control and treatment response

  4. Step 4

    6-month follow-up

    Another medical examination will be performed to monitor lung health

    You will complete quality of life questionnaires

    Your progress will continue to be evaluated

  5. Step 5

    9-month follow-up

    A medical examination will be conducted to check lung condition

    You will complete quality of life questionnaires

    Your progress will be assessed

  6. Step 6

    12-month final evaluation

    A final medical examination will be performed to evaluate long-term lung health

    You will complete the final set of quality of life questionnaires

    Overall treatment outcomes will be assessed

    Your survival and disease progression status will be evaluated

Who can join the trial?

6 criteria

  • Must be 18 years of age or older
  • Must be diagnosed with primary lung tumors (tumors that started in the lung) or secondary lung tumors (tumors that spread to the lung from other parts of the body)
  • Must be scheduled to receive SBRT treatment (Stereotactic Body Radiation Therapy - a precise form of radiation therapy that uses high doses of radiation delivered to specific areas of the body)
  • Can be either male or female
  • Must be able to undergo lung perfusion PET/CT imaging (a special type of scan that shows how blood flows through the lungs)
  • Must not belong to any vulnerable population groups (such as people who cannot make decisions for themselves)

Who cannot join the trial?

12 criteria

  • Age below 18 years old
  • Inability to provide informed consent
  • Pregnant or breastfeeding women
  • Previous radiation therapy to the chest area
  • Active lung infections (diseases currently affecting the lungs)
  • Presence of multiple tumors that cannot be treated with SBRT (specialized high-precision radiation therapy)
  • Severe breathing problems that prevent lying still during treatment
  • Known allergies to contrast agents used in PET/CT imaging (special type of medical scanning)
  • Medical conditions that prevent undergoing PET/CT scanning
  • Participation in other clinical trials that could interfere with this study
  • Mental or physical conditions that could interfere with following the study protocol
  • Inability to attend follow-up visits for one year after treatment
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Investigated drugs

  • Stereotactic Body Radiotherapy (SBRT)

    This is a highly precise form of radiation therapy that delivers focused radiation beams to tumors in the lungs. It uses special equipment and imaging techniques to deliver high doses of radiation while minimizing exposure to surrounding healthy tissue.

  • PET/CT-guided Radiation Planning

    This is an advanced treatment planning method that uses combined PET (Positron Emission Tomography) and CT (Computed Tomography) scans to map out areas of lung function. This helps doctors plan radiation treatment by identifying which areas of the lung are most active and functional, allowing them to better avoid damaging healthy, well-functioning lung tissue during treatment.

What is already known about the treatment

Since this clinical trial data doesn't mention any specific medications (it's focused on radiotherapy treatment and imaging techniques), I cannot provide medication descriptions in the requested format. The trial is about comparing different radiotherapy planning methods (functional planning using lung perfusion PET/CT versus conventional anatomical planning) for stereotactic body radiotherapy (SBRT) in patients with lung tumors. No pharmaceutical interventions are specified in the provided data. If you'd like medication descriptions, you would need to provide trial data that includes specific pharmaceutical interventions.

Investigated diseases

  • Primary Lung Cancer

    A disease that starts in the lungs when normal cells begin growing abnormally and form tumors. It develops directly in the lung tissue, typically beginning in the cells lining the bronchi and other parts of the lung. The disease can affect lung function and breathing capacity as it progresses.

  • Secondary Lung Cancer

    A condition where cancer cells from other parts of the body spread to the lungs, forming new tumors. These metastatic tumors are not original lung cancer but rather cancer that has traveled through the bloodstream or lymphatic system to establish itself in lung tissue. The disease can affect multiple areas of the lungs simultaneously.

  • Radiation-Induced Lung Injury (RILI)

    A condition that can develop in lung tissue following radiation therapy. It involves inflammation and potential scarring of lung tissue that occurs as a response to radiation exposure. The condition can affect breathing capacity and may develop within months after radiation treatment.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519465-22-01Protocol code29BRC23.0220Estimated enrolment418 patientsSponsorCentre Hospitalier Regional Et Universitaire De Brest

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