SBRTPhase 2/3PEGASUSNCT04942275
Lung Perfusion PET / CT Using Ga68-MAA for Preservation of Lung Function During Stereotactic Pulmonary Radiation Therapy
A Phase 2/3 study testing Pre-therapeutic imaging test in people with SBRT and Non-small Cell Lung Cancer, run by University Hospital, Brest at 1 site in France.
Trial summary
This is a prospective study evaluating the feasibility of treatment planning integrating lung perfusion PET/CT using Ga68-MAA to preserve functional lung areas during stereotactic body radiation therapy (SBRT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SBRT, Non-small Cell Lung Cancer, Lung Metastasis
- What is being tested?
- Pre-therapeutic imaging test
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2021to 30 Sep 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 >18 years
- Insured patient
- Patient treated at the Brest CHRU for SBRT of a primary or secondary pulmonary lesion
Who cannot join
- Unable/unwilling to give informed consent
- Pregnancy / breast-feeding patient
- Patient under guardianship or curatorship
- Patient with contraindication to the administration of macroaggregates of human albumin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lung Perfusion PET / CT Using Gallium68-MMA for Preservation of Lung Function During Stereotactic Pulmonary Radiation Therapy
This is a prospective study evaluating the feasibility of treatment planning integrating lung perfusion PET/CT using Ga68-MAA to preserve functional lung areas during stereotactic body radiation therapy (SBRT).
Read the detailed description
Lung perfusion PET / CT is a new imaging modality based on the use of the same cold molecules as those used for a conventional perfusion lung scan. Similartly, perfusion images are obtained after intravenous administration of human albumin macroaggregates, which are embolized in pulmonary capillaries according to pulmonary blood flow. However, these cold molecules are radiolabeled, not with Technetium99m, but with Gallium68, a ß + isotope, allowing image acquisition with PET technology. The same physiological processes are therefore observed with conventional scintigraphy PET imaging, but PET is an intrinsically superior technique for image acquisition, with greater sensitivity, better spatial and temporal resolutions and the possibility to perform respiratory-gated acquisition, allowing a better definition of the pulmonary functional volumes.
The aim is to evaluate the feasability of functional lung avoidance planification using lung perfusion PET/CT imaging during SBRT.
Patients will benefit from a pre-treatment functional assessment including PET/CT imaging.
The treatment planning will be carried out in 2 stages:
- First, an anatomical planning will be carried out, blinded to the PET results.
- Then, a functional planning, respecting the standard constraints applied during anatomical planning, but also incorporating a new "functional lung volume" constraint defined by PET/CT images, will be carried out.
A follow-up will be carried out for 12 months, including repeated perfusion PET/CT imaging at 3 and 12 months.
- Conditions
- SBRT, Non-small Cell Lung Cancer, Lung Metastasis
- Being tested
- Pre-therapeutic imaging test
- Keywords
- Perfusion imaging, Positron EmissionTomography, Lung cancer, SBRT, Radiation induced lung injury
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-therapeutic imaging testDrug
The radiopharmaceutical used for lung perfusion PET consists in human albumin macroaggregates labeled with Ga-68 (68Ga-MAA). 68Ga- MAA are administrated intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Intervention : Lung perfusion PET/CT using Ga68-MAA and SBRT planification | Experimental | All patients included for treatment with stereotactic radiotherapy for non-small cell lung cancer or lung metastasis will benefit from a pre-therapeutic functional assessment including:
* The standard functional assessment recommended before performing an SBRT.
* A perfusion PET/CT scan
The treatment planning will be carried out in 2 stages:
* First, an anatomical planning will be carried out, blinded to the PET results.
* Then, a functional planning, respecting the standard constraints applied during anatomical planning, but also incorporating a new "functional lung volume" constraint defined by pulmonary PET, will then be carried out.
A follow-up will be carried out for 12 months, including repeated perfusion PET/CT imaging at 3 and 12 months Receives: Drug: Pre-therapeutic imaging test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients with a dose reduction to the functional lung (estimated during functional planning).
Percentage of patients for whom it is possible to reduce the dose to the functional lung (estimated during the functional planning).
A reduction in the dose to the functional lung will be defined by:
- A decrease of at least 5% in functional lung volume included in V20Gy. or
- A decrease of at least 5% in total relative lung function included in the V20G.
Measured: Baseline, one week after lung perfusion PET / CT scan using Ga68-MAA
Secondary outcomes (30)
Impact of lung perfusion PET / CT scan on lung activity during SBRT (stereotactic body radiation therapy) planning
Percentage of activity included in the V20Gy with the anatomical planning and the functional planning.
Measured: Baseline, one week after lung perfusion PET / CT scan using Ga68-MAA
Impact of lung perfusion PET / CT scan on lung activity during SBRT (stereotactic body radiation therapy) planning
Percentage of functional lung volume included in the V20Gy with anatomical planning and during functional planning
Measured: Baseline, one week after lung perfusion PET / CT scan using Ga68-MAA
Pulmonary toxicity at 3 months
Pulmonary toxicity defined according to EORTC (European Organisation for Research and Treatment of Cancer) criteria (Common Terminology Criteria for Adverse Events 5.0, EORTC QLQ-C30 : European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire - Cancer module 30) at 3 months
Measured: At 3 months after SBRT (stereotactic body radiation therapy)
Pulmonary toxicity at 3 months
Pulmonary toxicity defined according to EORTC (European Organisation for Research and Treatment of Cancer) criteria (Common Terminology Criteria for Adverse Events 5.0, EORTC QLQ-LC13 :European Organisation for Research and Treatment of Cancer- Quality of Life Questionnaire - Lung Cancer module 13) at 3 months
Measured: At 3 months after SBRT( stereotactic body radiation therapy)
Pulmonary toxicity at 6 months
Pulmonary toxicity defined according to EORTC (European Organisation for Research and Treatment of Cancer) criteria (Common Terminology Criteria for Adverse Events 5.0, EORTC QLQ-C30 : European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire -Cancer module 30) at 6 months
Measured: At 6 months after SBRT (stereotactic body radiation therapy)
Pulmonary toxicity at 6 months
Pulmonary toxicity defined according to EORTC (European Organisation for Research and Treatment of Cancer) criteria (Common Terminology Criteria for Adverse Events 5.0, EORTC QLQ-LC13 : European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire - Lung Cancer module 13) at 6 months
Measured: At 6 months after SBRT (stereotactic body radiation therapy)
Pulmonary toxicity at 9 months
Pulmonary toxicity defined according to EORTC (European Organisation for Research and Treatment of Cancer) criteria (Common Terminology Criteria for Adverse Events 5.0, EORTC QLQ-C30 : European Organisation for Research and Treatment of Cancer -Quality of Life Questionnaire - Cancer module 30) at 9 months
Measured: At 9 months after SBRT (stereotactic body radiation therapy)
Pulmonary toxicity at 9 months
Pulmonary toxicity defined according to EORTC (European Organisation for Research and Treatment of Cancer) criteria (Common Terminology Criteria for Adverse Events 5.0, EORTC QLQ-LC13 : European Organisation for Research and Treatment of Cancer -Quality of Life Questionnaire - Lung Cancer module 13) at 9 months
Measured: At 9 months after SBRT (stereotactic body radiation therapy)
Pulmonary toxicity at 12 months
Pulmonary toxicity defined according to EORTC (European Organisation for Research and Treatment of Cancer) criteria (Common Terminology Criteria for Adverse Events 5.0, EORTC QLQ-C30 : European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire - Cancer module 30) at 12 months
Measured: At 12 months after SBRT (stereotactic body radiation therapy)
Pulmonary toxicity at 12 months
Pulmonary toxicity defined according to EORTC (European Organisation for Research and Treatment of Cancer) criteria (Common Terminology Criteria for Adverse Events 5.0, EORTC QLQ-LC13 : European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire - Lung Cancer module 13) at 12 months
Measured: At 12 months after SBRT (stereotactic body radiation therapy)
Dyspnea at Day 0 (inclusion)
Results of EuroQol (EQ-5D-5L) questionnaire
Measured: Baseline, Day 0
Dyspnea at Day 0 (inclusion)
Results of Pulmonary Function testing (PFT) : FEV1
Measured: Baseline, Day 0
Dyspnea at Day 0 (inclusion)
Results of Pulmonary Function testing (PFT) : FEV1/FVC
Measured: Baseline, Day 0
Dyspnea at Day 0 (inclusion)
Results of 6 minutes Walk Test (6MWT)
Measured: Baseline, Day 0
Dyspnea at 3 months
Results of EuroQol (EQ-5D-5L) questionnaire
Measured: At 3 months after SBRT (stereotactic body radiation therapy)
Dyspnea at 3 months
Results of Pulmonary Function testing (PFT) : FEV1
Measured: At 3 months after SBRT (stereotactic body radiation therapy)
Dyspnea at 3 months
Results of Pulmonary Function testing (PFT) : FEV1/FVC
Measured: At 3 months after SBRT (stereotactic body radiation therapy)
Dyspnea at 3 months
Results of 6 minutes Walk Test (6MWT)
Measured: At 3 months after SBRT (stereotactic body radiation therapy)
Dyspnea at 6 months
Results of EuroQol (EQ-5D-5L) questionnaire
Measured: At 6 months after SBRT (stereotactic body radiation therapy)
Dyspnea at 6 months
Results of Pulmonary Function testing (PFT) : FEV1
Measured: At 6 months after SBRT (stereotactic body radiation therapy)
Dyspnea at 6 months
Results of Pulmonary Function testing (PFT) : FEV1/FVC
Measured: At 6 months after SBRT (stereotactic body radiation therapy)
Dyspnea at 6 months
Results of 6 minutes Walk Test (6MWT)
Measured: At 6 months after SBRT (stereotactic body radiation therapy)
Dyspnea at 9 months
Results of EuroQol (EQ-5D-5L) questionnaire
Measured: At 9 months after SBRT (stereotactic body radiation therapy)
Dyspnea at 9 months
Results of Pulmonary Function testing (PFT) : FEV1
Measured: At 9 months after SBRT (stereotactic body radiation therapy)
Dyspnea at 9 months
Results of Pulmonary Function testing (PFT) : FEV1/FVC
Measured: At 9 months after SBRT (stereotactic body radiation therapy)
Dyspnea at 9 months
Results of 6 minutes Walk Test (6MWT)
Measured: At 9 months after SBRT (stereotactic body radiation therapy)
Dyspnea at 12 months
Results of EuroQol (EQ-5D-5L) questionnaire
Measured: At 12 months after SBRT (stereotactic body radiation therapy)
Dyspnea at 12 months
Results of Pulmonary Function testing (PFT) : FEV1
Measured: At 12 months after SBRT (stereotactic body radiation therapy)
Dyspnea at 12 months
Results of Pulmonary Function testing (PFT) : FEV1/FVC
Measured: At 12 months after SBRT (stereotactic body radiation therapy)
Dyspnea at 12 months
Results of 6 minutes Walk Test (6MWT)
Measured: At 12 months after SBRT (stereotactic body radiation therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start15 Jul 2021
- Primary completion30 Jul 2022
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SBRTStudies 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 2/3
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942275
- Sponsor's protocol ID
- 29BRC21.0131
- Acronym
- PEGASUS
- Status last verified
- Sep 2022
- First submitted
- 9 Jun 2021
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Publications
Le Roux PY, Le Pennec R, Bourbonne V, Blanc-Beguin F, Pavoine M, Kerleguer K, Mauguen M, Pradier O, Salaun PY, Lucia F, Bourhis D. Pulmonary uptake value (PUV): a new quantification method for lung PET/CT imaging. EJNMMI Res. 2025 Jul 1;15(1):79. doi: 10.1186/s13550-025-01274-y.
PubMed 40591115
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Perfusion PET / CT Using Gallium68-MMA for Preservation of Lung Function During Stereotactic Pulmonary Radiation Therapy
- ClinicalTrials.gov ID
- NCT04942275
- Acronym / sponsor ID
- PEGASUS / 29BRC21.0131
- Conditions
- SBRT, Non-small Cell Lung Cancer, Lung Metastasis
- Keywords
- Perfusion imaging, Positron EmissionTomography, Lung cancer, SBRT, Radiation induced lung injury
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 28 Jun 2021 (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.
This is a prospective study evaluating the feasibility of treatment planning integrating lung perfusion PET/CT using Ga68-MAA to preserve functional lung areas during stereotactic body radiation therapy (SBRT).
Detailed description
Lung perfusion PET / CT is a new imaging modality based on the use of the same cold molecules as those used for a conventional perfusion lung scan. Similartly, perfusion images are obtained after intravenous administration of human albumin macroaggregates, which are embolized in pulmonary capillaries according to pulmonary blood flow. However, these cold molecules are radiolabeled, not with Technetium99m, but with Gallium68, a ß + isotope, allowing image acquisition with PET technology. The same physiological processes are therefore observed with conventional scintigraphy PET imaging, but PET is an intrinsically superior technique for image acquisition, with greater sensitivity, better spatial and temporal resolutions and the possibility to perform respiratory-gated acquisition, allowing a better definition of the pulmonary functional volumes.
The aim is to evaluate the feasability of functional lung avoidance planification using lung perfusion PET/CT imaging during SBRT.
Patients will benefit from a pre-treatment functional assessment including PET/CT imaging.
The treatment planning will be carried out in 2 stages:
- First, an anatomical planning will be carried out, blinded to the PET results.
- Then, a functional planning, respecting the standard constraints applied during anatomical planning, but also incorporating a new "functional lung volume" constraint defined by PET/CT images, will be carried out.
A follow-up will be carried out for 12 months, including repeated perfusion PET/CT imaging at 3 and 12 months.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention : Lung perfusion PET/CT using Ga68-MAA and SBRT planification | Experimental | Drug: Pre-therapeutic imaging testAll patients included for treatment with stereotactic radiotherapy for non-small cell lung cancer or lung metastasis will benefit from a pre-therapeutic functional assessment including: * The standard functional assessment recommended before performing an SBRT. * A perfusion PET/CT scan The treatment planning will be carried out in 2 stages: * First, an anatomical planning will be carried out, blinded to the PET results. * Then, a functional planning, respecting the standard constraints applied during anatomical planning, but also incorporating a new "functional lung volume" constraint defined by pulmonary PET, will then be carried out. A follow-up will be carried out for 12 months, including repeated perfusion PET/CT imaging at 3 and 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years
- Insured patient
- Patient treated at the Brest CHRU for SBRT of a primary or secondary pulmonary lesion
Key exclusion criteria (4 listed)
- Unable/unwilling to give informed consent
- Pregnancy / breast-feeding patient
- Patient under guardianship or curatorship
- Patient with contraindication to the administration of macroaggregates of human albumin
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 |
|---|---|---|
| Pre-therapeutic imaging testThe radiopharmaceutical used for lung perfusion PET consists in human albumin macroaggregates labeled with Ga-68 (68Ga-MAA). 68Ga- MAA are administrated intravenously. | Drug | Intervention : Lung perfusion PET/CT using Ga68-MAA and SBRT planification |
Primary outcome
Patients with a dose reduction to the functional lung (estimated during functional planning).
Time frame: Baseline, one week after lung perfusion PET / CT scan using Ga68-MAA
Percentage of patients for whom it is possible to reduce the dose to the functional lung (estimated during the functional planning). A reduction in the dose to the functional lung will be defined by: * A decrease of at least 5% in functional lung volume included in V20Gy. or * A decrease of at least 5% in total relative lung function included in the V20G.
30 secondary outcomes
Impact of lung perfusion PET / CT scan on lung activity during SBRT (stereotactic body radiation therapy) planning
Time frame: Baseline, one week after lung perfusion PET / CT scan using Ga68-MAA
Impact of lung perfusion PET / CT scan on lung activity during SBRT (stereotactic body radiation therapy) planning
Time frame: Baseline, one week after lung perfusion PET / CT scan using Ga68-MAA
Pulmonary toxicity at 3 months
Time frame: At 3 months after SBRT (stereotactic body radiation therapy)
Pulmonary toxicity at 3 months
Time frame: At 3 months after SBRT( stereotactic body radiation therapy)
Pulmonary toxicity at 6 months
Time frame: At 6 months after SBRT (stereotactic body radiation therapy)
Pulmonary toxicity at 6 months
Time frame: At 6 months after SBRT (stereotactic body radiation therapy)
Pulmonary toxicity at 9 months
Time frame: At 9 months after SBRT (stereotactic body radiation therapy)
Pulmonary toxicity at 9 months
Time frame: At 9 months after SBRT (stereotactic body radiation therapy)
Pulmonary toxicity at 12 months
Time frame: At 12 months after SBRT (stereotactic body radiation therapy)
Pulmonary toxicity at 12 months
Time frame: At 12 months after SBRT (stereotactic body radiation therapy)
Dyspnea at Day 0 (inclusion)
Time frame: Baseline, Day 0
Dyspnea at Day 0 (inclusion)
Time frame: Baseline, Day 0
Dyspnea at Day 0 (inclusion)
Time frame: Baseline, Day 0
Dyspnea at Day 0 (inclusion)
Time frame: Baseline, Day 0
Dyspnea at 3 months
Time frame: At 3 months after SBRT (stereotactic body radiation therapy)
Dyspnea at 3 months
Time frame: At 3 months after SBRT (stereotactic body radiation therapy)
Dyspnea at 3 months
Time frame: At 3 months after SBRT (stereotactic body radiation therapy)
Dyspnea at 3 months
Time frame: At 3 months after SBRT (stereotactic body radiation therapy)
Dyspnea at 6 months
Time frame: At 6 months after SBRT (stereotactic body radiation therapy)
Dyspnea at 6 months
Time frame: At 6 months after SBRT (stereotactic body radiation therapy)
Dyspnea at 6 months
Time frame: At 6 months after SBRT (stereotactic body radiation therapy)
Dyspnea at 6 months
Time frame: At 6 months after SBRT (stereotactic body radiation therapy)
Dyspnea at 9 months
Time frame: At 9 months after SBRT (stereotactic body radiation therapy)
Dyspnea at 9 months
Time frame: At 9 months after SBRT (stereotactic body radiation therapy)
Dyspnea at 9 months
Time frame: At 9 months after SBRT (stereotactic body radiation therapy)
Dyspnea at 9 months
Time frame: At 9 months after SBRT (stereotactic body radiation therapy)
Dyspnea at 12 months
Time frame: At 12 months after SBRT (stereotactic body radiation therapy)
Dyspnea at 12 months
Time frame: At 12 months after SBRT (stereotactic body radiation therapy)
Dyspnea at 12 months
Time frame: At 12 months after SBRT (stereotactic body radiation therapy)
Dyspnea at 12 months
Time frame: At 12 months after SBRT (stereotactic body radiation therapy)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Derived from this study: PubMed 40591115Le Roux PY, Le Pennec R, Bourbonne V, Blanc-Beguin F, Pavoine M, Kerleguer K, Mauguen M, Pradier O, Salaun PY, Lucia F, Bourhis D. Pulmonary uptake value (PUV): a new quantification method for lung PET/CT imaging. EJNMMI Res. 2025 Jul 1;15(1):79. doi: 10.1186/s13550-025-01274-y.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
Related trials for SBRT
RecruitingPhase 1
Study to Evaluate CD8 PET Imaging as a Marker of Immune Response to Stereotactic Body Radiation Therapy (ELIXR)
Metastatic Malignant Solid Neoplasm, Lymphoma
Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
Active, not recruitingPhase 1
High-Dose Rate Brachytherapy and Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer
Prostate Cancer, Adenocarcinoma of the Prostate
Active, not recruiting
Pilot Study of SGRT Alone vs. SGRT With Fiducials for Breath Hold SBRT tx of the Lung
Lung Cancer
Active, not recruitingPhase 3
Stereotactic Body Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Stage IIA-B Prostate Cancer
Stage II Prostate Adenocarcinoma AJCC v7
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pre-therapeutic imaging test in people with SBRT and Non-small Cell Lung Cancer, run by University Hospital, Brest at 1 site in France.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 19 Sep 2022. 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 France. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients with a dose reduction to the functional lung (estimated during functional planning). (time frame: Baseline, one week after lung perfusion PET / CT scan using Ga68-MAA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04942275, which also lists 1 linked publication.
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 19 Sep 2022.