CancerNCT03501823
Development of Photoacoustic Tomography
An observational study of Cancer and Cardiovascular Diseases, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Cardiovascular Diseases
- What is being tested?
- Photoacoustic tomography
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Feb 2018to 1 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Andrew Plumb, BA, BMBCh, PhD, MRCP, FRCR contact
United Kingdom1 site, 1 recruiting
- Recruiting
University College London Hospital
London, NW1 2PG
Shankar Kumar, BSc, MBBS, shankar.kumar@nhs.net
Andrew Plumb, BA, BMBCh, PhD, MRCP, FRCR, andrew.plumb@nhs.net
About this study
Official title: Photoacoustic Tomography of Normal and Abnormal Vasculature: Feasibility of in Vivo Measurements.
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.
Read the detailed description
Cancer affects nearly 50% of individuals in the UK, and accounts for around 30% of all deaths. For almost all cancers, both prognosis and treatment fundamentally depend on the degree of spread at diagnosis i.e. tumour stage. For example, early stage bowel (colorectal) cancer confined to the bowel wall has a cure rate of nearly 95% whereas it is lower than 50% by the time it has spread to the lymph nodes (LNs). Similarly, patients with LN involvement from breast cancer may require more extensive surgery to remove the affected node, and have poorer long-term survival than patients without LN disease, even with small volumes of nodal tumour. The same is true for most other solid organ malignancies. So, as a general oncological principle, patients with advanced disease often require more aggressive treatment such as pre-operative (neo-adjuvant) chemotherapy, radiotherapy or both; and usually need more extensive surgery / radiotherapy when definitive treatment is instituted.
Such therapeutic decision-making depends fundamentally on the advance knowledge of whether or not a particular patient has disease spread. This, in turn, requires a battery of tests designed to accurately pinpoint the extent and anatomical location of cancer dissemination throughout the body. This is typically achieved via a combination of medical imaging tests (such as ultrasound, computed tomography [CT], magnetic resonance imaging [MRI] and nuclear medicine techniques e.g. positron emission tomography [PET]) and tissue sampling (biopsy). Unfortunately, these techniques are imperfect, both for local staging of the primary cancer and its spread to local LNs. For example, in some cancers, over 50% of malignant LNs measure less than 10mm, the most commonly-used cut-off to define an abnormal lymph node using conventional medical imaging[9]. Therefore, for many tumours it is common practice to treat the entire regional LN group, either by surgical removal or radiotherapy. This strategy risks overtreatment for many and introduces the adverse effects associated with such extensive tissue damage. Regarding primary tumours, the precise extent of local tumour spread can determine whether or not a limited, local resection can be achieved rather than a more radical excision. A rapid, non-invasive, well-tolerated test that could improve local and regional nodal cancer staging would be of great clinical value, since it would immediately permit more accurate individualized treatment strategies.
Photoacoustic tomography (PAT) is a relatively novel technology that may be able to help address this urgent clinical need. PAT relies upon the absorption of laser-generated light of specific wavelengths (often in the infra-red spectrum) by intrinsic components of the imaged tissue. Such absorption results in emission of sound waves, which are ultrasonic (i.e. very high frequency). Images can then be reconstructed in a similar manner to that employed by a clinical ultrasound scanner. By imaging at multiple wavelengths, tissue distribution of water, lipid (fat) and haemoglobin (in red blood cells and therefore blood vessels) can be mapped with extremely high resolution (~100 microns), raising the possibility that PAT can depict the small volume tumour that existing techniques cannot.
- Conditions
- Cancer, Cardiovascular Diseases
- Being tested
- Photoacoustic tomography
- Medical subject headings
- Neoplasms, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photoacoustic tomographyOther
A non-invasive, safe modality that relies on light and sound to generate images.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Photoacoustic tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (1)
Dimension of smallest blood vessels resolvable by PAT
Using full-width at half maximum, FWHM, to define the margins of a resolvable vessel
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start23 Feb 2018
- Primary completion1 Nov 2018 (estimated)
- Study completion1 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501823
- Sponsor's protocol ID
- 16/0248
- Status last verified
- Apr 2018
- First submitted
- 10 Apr 2018
- Last updated
- 18 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 17899293Zackrisson 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.
PubMed 24514041Guggenheim 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.
PubMed 26008874Moulding 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.
PubMed 15208061Zhang 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.
PubMed 18239717
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photoacoustic Tomography of Normal and Abnormal Vasculature: Feasibility of in Vivo Measurements.
- ClinicalTrials.gov ID
- NCT03501823
- Acronym / sponsor ID
- 16/0248
- Conditions
- Cancer, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- 1 Nov 2018 (estimated)
- Study completion
- 1 Nov 2018 (estimated)
- First posted
- 18 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cancer affects nearly 50% of individuals in the UK, and accounts for around 30% of all deaths. For almost all cancers, both prognosis and treatment fundamentally depend on the degree of spread at diagnosis i.e. tumour stage. For example, early stage bowel (colorectal) cancer confined to the bowel wall has a cure rate of nearly 95% whereas it is lower than 50% by the time it has spread to the lymph nodes (LNs). Similarly, patients with LN involvement from breast cancer may require more extensive surgery to remove the affected node, and have poorer long-term survival than patients without LN disease, even with small volumes of nodal tumour. The same is true for most other solid organ malignancies. So, as a general oncological principle, patients with advanced disease often require more aggressive treatment such as pre-operative (neo-adjuvant) chemotherapy, radiotherapy or both; and usually need more extensive surgery / radiotherapy when definitive treatment is instituted.
Such therapeutic decision-making depends fundamentally on the advance knowledge of whether or not a particular patient has disease spread. This, in turn, requires a battery of tests designed to accurately pinpoint the extent and anatomical location of cancer dissemination throughout the body. This is typically achieved via a combination of medical imaging tests (such as ultrasound, computed tomography [CT], magnetic resonance imaging [MRI] and nuclear medicine techniques e.g. positron emission tomography [PET]) and tissue sampling (biopsy). Unfortunately, these techniques are imperfect, both for local staging of the primary cancer and its spread to local LNs. For example, in some cancers, over 50% of malignant LNs measure less than 10mm, the most commonly-used cut-off to define an abnormal lymph node using conventional medical imaging[9]. Therefore, for many tumours it is common practice to treat the entire regional LN group, either by surgical removal or radiotherapy. This strategy risks overtreatment for many and introduces the adverse effects associated with such extensive tissue damage. Regarding primary tumours, the precise extent of local tumour spread can determine whether or not a limited, local resection can be achieved rather than a more radical excision. A rapid, non-invasive, well-tolerated test that could improve local and regional nodal cancer staging would be of great clinical value, since it would immediately permit more accurate individualized treatment strategies.
Photoacoustic tomography (PAT) is a relatively novel technology that may be able to help address this urgent clinical need. PAT relies upon the absorption of laser-generated light of specific wavelengths (often in the infra-red spectrum) by intrinsic components of the imaged tissue. Such absorption results in emission of sound waves, which are ultrasonic (i.e. very high frequency). Images can then be reconstructed in a similar manner to that employed by a clinical ultrasound scanner. By imaging at multiple wavelengths, tissue distribution of water, lipid (fat) and haemoglobin (in red blood cells and therefore blood vessels) can be mapped with extremely high resolution (~100 microns), raising the possibility that PAT can depict the small volume tumour that existing techniques cannot.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peripheral vascular disease | – | Other: Photoacoustic tomographyAll 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 |
| Oncology | – | Other: Photoacoustic tomographyAll 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photoacoustic tomographyA non-invasive, safe modality that relies on light and sound to generate images. | Other | Oncology, Peripheral vascular disease |
Primary outcome
The proportion of PAT acquisitions in which the target lymph node is visible, as judged by the mean of both readers' qualitative scores
Time frame: 1 year
Mean score of 2 or above
1 secondary outcome
Dimension of smallest blood vessels resolvable by PAT
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Background: PubMed 17899293Chen 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.
- Background: PubMed 24514041Zackrisson 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.
- Background: PubMed 26008874Guggenheim 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.
- Background: PubMed 15208061Moulding 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.
- Background: PubMed 18239717Zhang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Plumb, BA, BMBCh, PhD, MRCP, FRCR contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Cardiovascular Diseases, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shankar Kumar, BSc (hons) MBBS (020 3447 9070, shankar.kumar@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of PAT acquisitions in which the target lymph node is visible, as judged by the mean of both readers' qualitative scores (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03501823, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.