Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04783272
Status:
WITHDRAWN
Last Update Posted:
2023-06-07
First Post:
2021-02-17
Brief Title:
Photoacoustic Computed Tomography for Pre-Operative Reconstructive Flap Angiography
Sponsor:
Cedars-Sinai Medical Center
Organization:
Cedars-Sinai Medical Center
Study Overview
Official Title:
Photoacoustic Computed Tomography for Pre-Operative Reconstructive Flap Angiography - Pilot Study
Status:
WITHDRAWN
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to use equipment at partner institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if a new non-invasive imaging technology called Photoacoustic Computed Tomography PACT can be used in the pre-operative setting to better visualize the blood supply of reconstructive flaps used in Plastic Surgery
Detailed Description:
Photoacoustic Computed Tomography PACT is a novel non-invasive imaging technique which can perform deep tissue imaging with high spatial resolution and optical contrast The system utilizes short-pulsed lasers to generate photoacoustic waves in biological tissues These are then detected by a 512-element full-ring transducer array which allows for high spatial resolution especially in deep tissues In addition PACT utilizes diffuse optical tomography in which the light absorption of hemoglobin at visible or near-infrared wavelengths provides excellent contrast for the imaging of human vasculature
Prior studies of PACT imaging have evaluated this technique to image the human breast as an alternative modality for breast cancer screening as well as to image human extremities for the evaluation of vascular disease The full-ring transducer array offers a significant advantage in spatial resolution especially in deep tissues over the standard linear arrays employed in the standard widely-used handheld ultrasonic transducers In addition diffuse optical tomography allows for strong vascular contrast over a large field of view without the use of exogenous contrast agents
Flap reconstructive surgery utilizes a patients own soft tissues to recreate structures fill large soft tissue defects provide joint coverage or perform other reconstructive operations Examples of patients who would require flap reconstructive surgery include patients undergoing mastectomies and patients who have suffered from trauma with significant tissue loss Tissue flaps have a defined blood supply which originate from the original site of the tissue The flap can be compromised if the arterial supply or venous drainage is jeopardized during tissue transfer Therefore an accurate understanding of the blood supply of the tissue flap is crucial for successful flap reconstructive surgery
Current pre-operative vascular imaging modalities for flap reconstructive surgery include handheld Doppler ultrasonography magnetic resonance angiography MRA and the gold standard computed tomography angiography CTA Doppler ultrasonography is technician-dependent inaccurate and lacks optical contrast MRA is expensive requires a lengthy imaging time and requires the administration of intravenous contrast CTA is also expensive also requires the administration of intravenous contrast and requires the administration of ionizing radiation PACT does not require the administration of intravenous contrast or ionizing radiation and provides excellent spatial resolution and optical contrast Therefore PACT would be an optimal pre-operative vascular imaging modality for flap reconstructive surgery
Prior studies of PACT imaging have evaluated this technique to image the human breast as an alternative modality for breast cancer screening as well as to image human extremities for the evaluation of vascular disease The full-ring transducer array offers a significant advantage in spatial resolution especially in deep tissues over the standard linear arrays employed in the standard widely-used handheld ultrasonic transducers In addition diffuse optical tomography allows for strong vascular contrast over a large field of view without the use of exogenous contrast agents
Flap reconstructive surgery utilizes a patients own soft tissues to recreate structures fill large soft tissue defects provide joint coverage or perform other reconstructive operations Examples of patients who would require flap reconstructive surgery include patients undergoing mastectomies and patients who have suffered from trauma with significant tissue loss Tissue flaps have a defined blood supply which originate from the original site of the tissue The flap can be compromised if the arterial supply or venous drainage is jeopardized during tissue transfer Therefore an accurate understanding of the blood supply of the tissue flap is crucial for successful flap reconstructive surgery
Current pre-operative vascular imaging modalities for flap reconstructive surgery include handheld Doppler ultrasonography magnetic resonance angiography MRA and the gold standard computed tomography angiography CTA Doppler ultrasonography is technician-dependent inaccurate and lacks optical contrast MRA is expensive requires a lengthy imaging time and requires the administration of intravenous contrast CTA is also expensive also requires the administration of intravenous contrast and requires the administration of ionizing radiation PACT does not require the administration of intravenous contrast or ionizing radiation and provides excellent spatial resolution and optical contrast Therefore PACT would be an optimal pre-operative vascular imaging modality for flap reconstructive surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None