Functional Lung Avoidance Planning Using [68Ga]Ga-MAA PET/CT Versus Anatomical Planning in SBRT for Primary or Secondary Lung Tumors: A Randomized Controlled Trial

The primary objective is to evaluate whether functional planning guided by lung perfusion PET/CT is superior to conventional anatomical planning in reducing the occurrence of grade 2 or higher lung toxicity during the first year following stereotactic body radiotherapy (SBRT) for lung tumors. 2: 5

Secondary objectives include:

• Comparison of quality of life between the two planning modalities.
• Assessment of the frequency of radiation-induced lung injury (RILI) of grade 2 or higher and grade 3 or higher.
• Evaluation of progression-free survival and overall survival.
• Analysis of the predictive value of radiation doses delivered to functional lung volumes versus anatomical lung volumes on long-term toxicity at 12 months.
• Determination of the predictive value of doses delivered to functional volumes on lung perfusion imaging at 3 months.
• Investigation of the predictive value of decreased lung perfusion at 3 months regarding long-term lung toxicity at 12 months.

The sponsor did not provide information regarding the total number of participants. The study population consists of adults, including both males and females, who are scheduled to undergo stereotactic body radiotherapy (SBRT) for either primary lung cancer or secondary lung tumors. Eligible participants are aged over 18 years. The investigation aims to evaluate the incidence of lung toxicity, specifically grade 2 or higher, following treatment.

This double-blinded, randomized, controlled trial compares functional lung avoidance planning guided by lung perfusion PET/CT imaging against conventional anatomical planning for patients undergoing stereotactic body radiotherapy (SBRT) for primary or secondary lung tumors. The experimental arm utilizes [68Ga]Ga-MAA administered via intravenous injection. The primary objective is to evaluate the occurrence of symptomatic radiation-induced lung injury (RILI), specifically grade 2 or higher lung toxicity as assessed by CTCAE 5.0, during the twelve months following treatment. Study procedures include a screening process to identify eligible participants, followed by treatment planning and radiotherapy. Subsequent follow-up assessments are conducted at 3, 6, 9, and 12 months to monitor quality of life via standardized questionnaires, local tumor control, progression-free survival, and overall survival. Additional evaluations at the 3-month mark include lung perfusion PET/CT imaging to assess the predictive value of dose delivery to functional volumes. The total duration of participant involvement is one year following the SBRT procedure.

The experimental treatment consists of [68Ga]Ga-MAA, a solution containing gallium (68ga) and human albumin as macroaggregates. This substance is administered via an intravenous route at a dosage of 200 MBq.

The primary efficacy endpoint is the occurrence of symptomatic radiation-induced lung injury (RILI), defined as lung toxicity of grade 2 or higher according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0). This assessment is performed by a blinded medical oncologist during the one-year period following stereotactic body radiotherapy (SBRT).

Secondary endpoints include quality of life assessments using the EORTC QLQ-C30, EORTC QLQ-LC29, and EQ-5D-5L questionnaires at 3, 6, 9, and 12 months. Lung toxicity is further evaluated at 3, 6, 9, and 12 months using the CTCAE 5.0, RTOG, and LENT-SOMA scales. Additional secondary parameters evaluated at specified intervals include local tumor control, progression-free survival at 3, 6, 9, and 12 months, and overall survival at 12 months. Lung perfusion PET/CT imaging is conducted at 3 months to evaluate the predictive value of doses delivered to lung functional volumes compared to anatomical volumes, as well as the predictive value of decreased lung perfusion on long-term toxicity at 12 months.