Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04942275
Other study ID # 29BRC21.0131
Secondary ID
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date July 15, 2021
Est. completion date September 30, 2023

Study information

Verified date September 2022
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date September 30, 2023
Est. primary completion date July 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age >18 years - Insured patient - Patient treated at the Brest CHRU for SBRT of a primary or secondary pulmonary lesion Exclusion Criteria: - 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

Study Design


Intervention

Drug:
Pre-therapeutic imaging test
The radiopharmaceutical used for lung perfusion PET consists in human albumin macroaggregates labeled with Ga-68 (68Ga-MAA). 68Ga- MAA are administrated intravenously.

Locations

Country Name City State
France CHRU de Brest Brest Brest Cedex

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Baseline, one week after lung perfusion PET / CT scan using Ga68-MAA
Secondary 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. Baseline, one week after lung perfusion PET / CT scan using Ga68-MAA
Secondary 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 Baseline, one week after lung perfusion PET / CT scan using Ga68-MAA
Secondary 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 At 3 months after SBRT (stereotactic body radiation therapy)
Secondary 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 At 3 months after SBRT( stereotactic body radiation therapy)
Secondary 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 At 6 months after SBRT (stereotactic body radiation therapy)
Secondary 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 At 6 months after SBRT (stereotactic body radiation therapy)
Secondary 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 At 9 months after SBRT (stereotactic body radiation therapy)
Secondary 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 At 9 months after SBRT (stereotactic body radiation therapy)
Secondary 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 At 12 months after SBRT (stereotactic body radiation therapy)
Secondary 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 At 12 months after SBRT (stereotactic body radiation therapy)
Secondary Dyspnea at Day 0 (inclusion) Results of EuroQol (EQ-5D-5L) questionnaire Baseline, Day 0
Secondary Dyspnea at Day 0 (inclusion) Results of Pulmonary Function testing (PFT) : FEV1 Baseline, Day 0
Secondary Dyspnea at Day 0 (inclusion) Results of Pulmonary Function testing (PFT) : FEV1/FVC Baseline, Day 0
Secondary Dyspnea at Day 0 (inclusion) Results of 6 minutes Walk Test (6MWT) Baseline, Day 0
Secondary Dyspnea at 3 months Results of EuroQol (EQ-5D-5L) questionnaire At 3 months after SBRT (stereotactic body radiation therapy)
Secondary Dyspnea at 3 months Results of Pulmonary Function testing (PFT) : FEV1 At 3 months after SBRT (stereotactic body radiation therapy)
Secondary Dyspnea at 3 months Results of Pulmonary Function testing (PFT) : FEV1/FVC At 3 months after SBRT (stereotactic body radiation therapy)
Secondary Dyspnea at 3 months Results of 6 minutes Walk Test (6MWT) At 3 months after SBRT (stereotactic body radiation therapy)
Secondary Dyspnea at 6 months Results of EuroQol (EQ-5D-5L) questionnaire At 6 months after SBRT (stereotactic body radiation therapy)
Secondary Dyspnea at 6 months Results of Pulmonary Function testing (PFT) : FEV1 At 6 months after SBRT (stereotactic body radiation therapy)
Secondary Dyspnea at 6 months Results of Pulmonary Function testing (PFT) : FEV1/FVC At 6 months after SBRT (stereotactic body radiation therapy)
Secondary Dyspnea at 6 months Results of 6 minutes Walk Test (6MWT) At 6 months after SBRT (stereotactic body radiation therapy)
Secondary Dyspnea at 9 months Results of EuroQol (EQ-5D-5L) questionnaire At 9 months after SBRT (stereotactic body radiation therapy)
Secondary Dyspnea at 9 months Results of Pulmonary Function testing (PFT) : FEV1 At 9 months after SBRT (stereotactic body radiation therapy)
Secondary Dyspnea at 9 months Results of Pulmonary Function testing (PFT) : FEV1/FVC At 9 months after SBRT (stereotactic body radiation therapy)
Secondary Dyspnea at 9 months Results of 6 minutes Walk Test (6MWT) At 9 months after SBRT (stereotactic body radiation therapy)
Secondary Dyspnea at 12 months Results of EuroQol (EQ-5D-5L) questionnaire At 12 months after SBRT (stereotactic body radiation therapy)
Secondary Dyspnea at 12 months Results of Pulmonary Function testing (PFT) : FEV1 At 12 months after SBRT (stereotactic body radiation therapy)
Secondary Dyspnea at 12 months Results of Pulmonary Function testing (PFT) : FEV1/FVC At 12 months after SBRT (stereotactic body radiation therapy)
Secondary Dyspnea at 12 months Results of 6 minutes Walk Test (6MWT) At 12 months after SBRT (stereotactic body radiation therapy)
See also
  Status Clinical Trial Phase
Terminated NCT03087448 - Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC) Phase 1
Recruiting NCT05042375 - A Trial of Camrelizumab Combined With Famitinib Malate in Treatment Naïve Subjects With PD-L1-Positive Recurrent or Metastatic Non-Small Cell Lung Cancer Phase 3
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Terminated NCT05414123 - A Therapy Treatment Response Trial in Patients With Leptomeningeal Metastases ((LM) Using CNSide
Recruiting NCT05059444 - ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Recruiting NCT05919537 - Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation Phase 1
Recruiting NCT05009836 - Clinical Study on Savolitinib + Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic NSCLC Phase 3
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Completed NCT03219970 - Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting.
Recruiting NCT05949619 - A Study of BL-M02D1 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer or Other Solid Tumors Phase 1/Phase 2
Recruiting NCT04054531 - Study of KN046 With Chemotherapy in First Line Advanced NSCLC Phase 2
Withdrawn NCT03519958 - Epidermal Growth Factor Receptor (EGFR) T790M Mutation Testing Practices in Hong Kong
Completed NCT03384511 - The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies. Phase 4
Terminated NCT02580708 - Phase 1/2 Study of the Safety and Efficacy of Rociletinib in Combination With Trametinib in Patients With mEGFR-positive Advanced or Metastatic Non-small Cell Lung Cancer Phase 1/Phase 2
Completed NCT01871805 - A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC) Phase 1/Phase 2
Terminated NCT04042480 - A Study of SGN-CD228A in Advanced Solid Tumors Phase 1
Recruiting NCT05919641 - LIVELUNG - Impact of CGA in Patients Diagnosed With Localized NSCLC Treated With SBRT
Completed NCT03656705 - CCCR-NK92 Cells Immunotherapy for Non-small Cell Lung Carcinoma Phase 1