Perioperative Specimen Imaging Using High-resolution 18F-FDG-PET-CT During Thoracic Surgery: a Pilot Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-07-31

Brief Summary

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In this pilot study the investigators propose the intraoperative use of a high-resolution PET-CT imaging system which can assess resection margins and lymph node status in the operating room. This will allow for a faster and stepwise assessment (estimated to be under 10 minutes per specimen), enabling the surgeon to decide on subsequent surgical steps after each previous assessment.

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Detailed Description

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Conditions

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Lung Neoplasms PET-CT Specimen Imager

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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18F-FDG AURA10 Specimen Imager

* Intravenous injection of radiotracer (18F-FDG) (study-specific)
* Thoracic surgery (standard-of-care; not study-specific)
* High-resolution specimen imaging using the AURA10 PET-CT specimen imager (study-specific)
* Postoperative histopathological analysis of specimen (standard-of-care)

Group Type EXPERIMENTAL

AURA10 Specimen Imager

Intervention Type DEVICE

High-resolution specimen imaging using the AURA10 PET-CT specimen imager during thoracic surgery.

Interventions

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AURA10 Specimen Imager

High-resolution specimen imaging using the AURA10 PET-CT specimen imager during thoracic surgery.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient is 18 years of age or older.
* Patient with suspected or confirmed lung malignancies
* Patient is indicated to undergo thoracic surgery.
* Patient is estimated to be compliant for study participation by the investigator.
* Patient has freely given his/her informed consent to participate in this study.

Exclusion Criteria

* Patient has general or local contra-indications for thoracic surgery.
* Patient has active infection.
* Blood glucose level over 200 mg/dL on the day of surgery.
* Pregnancy or lactation.
* Patient participated in other clinical studies with radiation exposure of more than 1 mSv in the past year

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No