Prospective Study for Transplant Optimization Using Functional Imaging (TROFI)

FLUIDDA

Status and phase: Terminated; Phase 2

Conditions: Bronchiolitis Obliterans; Lung Transplant Rejection

Treatments: Radiation: HRCT scans

Study type: Interventional

Funder types: Industry

Identifiers

NCT02488304

FLUI-2015-141

Details and patient eligibility

About

The objective of this study is to detect BOS in an early stage by using the outcome parameters generated by Functional Respiratory Imaging (FRI). Robust and automated segmentation algorithms will be developed for these parameters, focusing on quantitative computed tomography (CT) image analyses to provide the physician a more sensitive diagnostics tool. The evolution of rejection over time will be monitored using non-rigid image registration methods.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patient ≥ 18 years old
• Written informed consent obtained
• Patients who are planned to receive a lung transplant in the near future
• Female patient of childbearing potential who confirm that a contraception method was used at least 14 days before screening visit and will continue to use a contraception method during the study
• The patient must be able to perform the lung monitoring at home

Exclusion criteria

• Pregnant or lactating female
• Known history of or active airways or anastomotic complications requiring intervention such as stenting or dilation

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

HRCT scans

Experimental group

Description:

High Resolution Computed Tomography scans will be taken

Treatment:

Radiation: HRCT scans