Development of Photoacoustic Tomography

NCT03501823 | Unknown

• 1 other identifier: 16/0248
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Cancer is one of the leading causes of death internationally. When planning treatment for most cancers, it is important to know how far it has spread, including whether or not the cancer has spread to the local lymph nodes (LNs) because this affects the treatment strategy. This is termed "staging", and can be achieved by medical imaging, such as by ultrasound, computed tomography (CT) or magnetic resonance imaging (MRI) scans. However, these are imperfect, and sometimes incorrect treatment decisions are made because of errors in staging by imaging. Improved accuracy would be of great clinical value for almost all solid organ tumours. An emerging technique to address this is photoacoustic tomography (PAT), a non-invasive, safe modality that relies on light and sound to generate images. Laser light is applied to the area to be imaged; this is absorbed, and causes the illuminated tissue to emit ultrasound waves. These can be detected and turned into an image by post-processing techniques similar to those used in conventional diagnostic ultrasound. By changing the wavelength of light used, the technique can be adjusted to optimise detection of various body components, including fat, water and both oxygenated and deoxygenated blood. This means the images can represent tissue composition and function rather than just anatomical structure. Hitherto, most work on PAT has been on healthy volunteers, and has focused on imaging the vasculature. We would like to see whether we are able to generate images of deeper structures inside the body. Initially we will focus on patients with vascular disease, whom we expect to have abnormal blood vessels; and subsequently we will attempt to image tumours and LNs in patients with cancer.

Conditions

Cancer; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• The proportion of PAT acquisitions in which the target lymph node is visible, as judged by the mean of both readers' qualitative scores

  Mean score of 2 or above

  1 year

Secondary Outcomes (1)

• Dimension of smallest blood vessels resolvable by PAT

  1 year

Study Arms (2)

Peripheral vascular disease

All adult patients (aged 18 years and above) proven or highly suspected to have peripheral arterial or venous disease. Ultrasound to be performed first in order to correct Photoacoustic tomography positioning. Photoacoustic tomography to be performed after ultrasound

Other: Photoacoustic tomography

Oncology

All adult patients (ages 18 years and above) proven or highly suspected to have solid organ malignancy Ultrasound to be performed first in order to correct Photoacoustic tomography positioning. Photoacoustic tomography to be performed after ultrasound

Other: Photoacoustic tomography

Interventions

Photoacoustic tomography OTHER

A non-invasive, safe modality that relies on light and sound to generate images.

Oncology; Peripheral vascular disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potentially eligible participants will be identified by the direct care clinical team at outpatient clinics, who will inform potential participants of the existence of the study and its broad rationale. Those who wish to consider participation in the study will be provided with a patient information sheet which includes the contact details of the research team.

You may qualify if:

• Adults (aged over 18 years)
• Suspected or proven to have peripheral arterial or venous disease on the basis of physical examination, imaging or ankle-brachial pressure index.
• Able to provide informed consent

You may not qualify if:

• Aged 17 or under
• Unable to provide informed consent (e.g. due to dementia or severe mental illness)
• Skin condition precluding safe and/or comfortable placement of an ultrasound or PAT probe (e.g. active infection, ulcerating tumour)
• Oncology Cohort All adult patients with either (a) superficial primary tumours or (b) solid organ tumours with a propensity to spread to superficial lymph nodes will be potentially eligible. These include head and neck cancers, breast cancers, skin cancers including melanoma, low rectal and anal cancer, lung cancer and cancers of the upper gastrointestinal tract.
• Adults (aged over 18 years)
• have either a proven diagnosis of malignancy or be under active investigation for malignant disease.
• Able to provide informed consent

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London Hospital

London, NW1 2PG, United Kingdom

RECRUITING

Related Publications (5)

• Chen SL, Hoehne FM, Giuliano AE. The prognostic significance of micrometastases in breast cancer: a SEER population-based analysis. Ann Surg Oncol. 2007 Dec;14(12):3378-84. doi: 10.1245/s10434-007-9513-6. Epub 2007 Sep 26.

  PMID: 17899293 BACKGROUND

• Zackrisson S, van de Ven SMWY, Gambhir SS. Light in and sound out: emerging translational strategies for photoacoustic imaging. Cancer Res. 2014 Feb 15;74(4):979-1004. doi: 10.1158/0008-5472.CAN-13-2387. Epub 2014 Feb 10.

  PMID: 24514041 BACKGROUND

• Guggenheim JA, Allen TJ, Plumb A, Zhang EZ, Rodriguez-Justo M, Punwani S, Beard PC. Photoacoustic imaging of human lymph nodes with endogenous lipid and hemoglobin contrast. J Biomed Opt. 2015 May;20(5):50504. doi: 10.1117/1.JBO.20.5.050504.

  PMID: 26008874 BACKGROUND

• Moulding FJ, Roach SC, Carrington BM. Unusual sites of lymph node metastases and pitfalls in their detection. Clin Radiol. 2004 Jul;59(7):558-72. doi: 10.1016/j.crad.2003.12.003. No abstract available.

  PMID: 15208061 BACKGROUND

• Zhang E, Laufer J, Beard P. Backward-mode multiwavelength photoacoustic scanner using a planar Fabry-Perot polymer film ultrasound sensor for high-resolution three-dimensional imaging of biological tissues. Appl Opt. 2008 Feb 1;47(4):561-77. doi: 10.1364/ao.47.000561.

  PMID: 18239717 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Cardiovascular Diseases

Central Study Contacts

Shankar Kumar, BSc (hons) MBBS

CONTACT

020 3447 9070; shankar.kumar@nhs.net

Andrew Plumb, BA, BMBCh, PhD, MRCP, FRCR

CONTACT

andrew.plumb@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: April 18, 2018
• Study Start: February 23, 2018
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: April 18, 2018

Record last verified: 2018-04

Locations

GB (1)