Breast CarcinomaNCT03630601
Photoacoustic Imaging in Diagnosing Changes in Tumors in Participants With Breast Cancer, Sarcoma, Skin Cancer, or Soft Tissue Malignancy and Healthy Volunteers
A study testing Photoacoustic Imaging in people with Breast Carcinoma and Healthy Subject, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This pilot trial studies how well photoacoustic imaging works in diagnosing changes in tumors in participants with breast cancer, sarcoma, skin cancer, or soft tissue malignancy and healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Carcinoma, Healthy Subject, Malignant Soft Tissue Neoplasm
- What is being tested?
- Photoacoustic Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2018to 15 Mar 2023
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ALL GROUPS:
- No restriction on race or ethnic background.
- Subject must understand the investigational nature of the study and sign an independent Ethics Committee/Institutional Review Board approved written informed consent prior to receiving any study related procedure.
- HEALTHY VOLUNTEERS:
- No history of antimicrobial therapy or drug treatment including anti-hypertensive, diuretic, immunosuppressive or anti-depressant drugs in the previous 6-month period.
- No history of diabetes.
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- No history of cancer to the body site to be imaged.
- BREAST, SARCOMA, SKIN CANCER, AND SUPERFICIAL MALIGNANCY PATIENTS:
- Biopsy-proven aforementioned malignancy.
- SURGICAL FLAP PATIENTS:
- Need for plastic surgery reconstruction with a free or rotational flap.
Who cannot join
- Uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Unwilling or unable to follow protocol requirements or provide consent.
- Any condition which in the Investigator's opinion deems the subject an unsuitable candidate to undergo imaging procedure.
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: A Pilot Study of Photoacoustic Imaging (PAI)
This pilot trial studies how well photoacoustic imaging works in diagnosing changes in tumors in participants with breast cancer, sarcoma, skin cancer, or soft tissue malignancy and healthy volunteers. Photoacoustic imaging is a low-risk imaging method that provides information about the oxygenation of tissues using a combination of light and ultrasound techniques. Photoacoustic imaging uses a signal from hemoglobin to provide information on blood flow and oxygen levels, and it may be helpful in determining changes in tumors after chemotherapy or radiation treatment.
Read the detailed description
PRIMARY OBJECTIVES:
- To define the feasibility of the current photoacoustic imaging (PAI) technology in various groups of human subjects.
SECONDARY OBJECTIVES:
- To define the utility of the current PAI on various groups of human subjects.
II. When possible, via means of an existing data review, PAI will be correlated with standard imaging modalities performed on patients as routine part of clinical care or on protocol.
III. When possible, via means of an existing data review, PAI will be compared to pathologic specimens.
IV. When possible, via means of an existing data review, PAI data will be correlated with outcomes of patients to therapies they receive.
OUTLINE:
Participants undergo PAI on different parts of the body over 20 minutes for up to 5 imaging sessions for 6 months.
- Conditions
- Breast Carcinoma, Healthy Subject, Malignant Soft Tissue Neoplasm, Sarcoma, Skin Carcinoma
- Being tested
- Photoacoustic Imaging
- Medical subject headings
- Breast Neoplasms, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photoacoustic ImagingProcedure or surgery
Undergo PAI
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (photoacoustic imaging) | Experimental | Participants undergo PAI on different parts of the body over 20 minutes for up to 5 imaging sessions for 6 months. Receives: Procedure: Photoacoustic Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of photoacoustic imaging (PAI) to quantify tumor characteristics
This will be deemed a success if at least 3 imaging sessions produce a usable image. Usable datasets will be defined as those images with detectable PAI signal with minimal or no artifacts within the region of interest. This analysis will be done in the imaged sample, consisting of enrolled patients who attempt at least one imaging session. Patients who do not attempt at least one imaging session will be replaced.
Measured: Up to 6 months
Secondary outcomes (4)
Utility of serial PAI measurements
This will be explored by comparison with disease and outcome characteristics collected during routine cancer treatment, including standard imaging modalities, pathology results, and clinical outcomes. Results of these analyses are intended to inform development of early stage (Phase 1/2) clinical trials that consider PAI summaries as biomarkers for treatment response.
Measured: Up to 6 months
Serial PAI oxygenation measurements
This will be correlated with disease and patient characteristics using Analysis of Variance (ANOVA ) for categorical factors
Measured: Up to 6 months
Serial PAI oxygenation measurements
This will be correlated with disease and patient characteristics using OLS regression for continuous factors
Measured: Up to 6 months
Serial PAI oxygenation measurements
This will be correlated with disease and patient characteristics using Cox Regression models for progression and overall survival.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start28 Jun 2018
- Primary completion15 Mar 2023
- Study completion15 Mar 2023
Why it stopped: Diagnostic issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Anurag Singh, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630601
- Sponsor's protocol ID
- I 56617
- Other IDs
- NCI-2018-01424, I 56617, R01CA204636
- Status last verified
- Mar 2023
- First submitted
- 24 Jul 2018
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Photoacoustic Imaging (PAI)
- ClinicalTrials.gov ID
- NCT03630601
- Acronym / sponsor ID
- I 56617
- Conditions
- Breast Carcinoma, Healthy Subject, Malignant Soft Tissue Neoplasm, Sarcoma, Skin Carcinoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Diagnostic issues
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 15 Aug 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.
This pilot trial studies how well photoacoustic imaging works in diagnosing changes in tumors in participants with breast cancer, sarcoma, skin cancer, or soft tissue malignancy and healthy volunteers. Photoacoustic imaging is a low-risk imaging method that provides information about the oxygenation of tissues using a combination of light and ultrasound techniques. Photoacoustic imaging uses a signal from hemoglobin to provide information on blood flow and oxygen levels, and it may be helpful in determining changes in tumors after chemotherapy or radiation treatment.
Detailed description
PRIMARY OBJECTIVES:
- To define the feasibility of the current photoacoustic imaging (PAI) technology in various groups of human subjects.
SECONDARY OBJECTIVES:
- To define the utility of the current PAI on various groups of human subjects.
II. When possible, via means of an existing data review, PAI will be correlated with standard imaging modalities performed on patients as routine part of clinical care or on protocol.
III. When possible, via means of an existing data review, PAI will be compared to pathologic specimens.
IV. When possible, via means of an existing data review, PAI data will be correlated with outcomes of patients to therapies they receive.
OUTLINE:
Participants undergo PAI on different parts of the body over 20 minutes for up to 5 imaging sessions for 6 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (photoacoustic imaging) | Experimental | Procedure: Photoacoustic ImagingParticipants undergo PAI on different parts of the body over 20 minutes for up to 5 imaging sessions for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ALL GROUPS:
- No restriction on race or ethnic background.
- Subject must understand the investigational nature of the study and sign an independent Ethics Committee/Institutional Review Board approved written informed consent prior to receiving any study related procedure.
- HEALTHY VOLUNTEERS:
- No history of antimicrobial therapy or drug treatment including anti-hypertensive, diuretic, immunosuppressive or anti-depressant drugs in the previous 6-month period.
Key exclusion criteria (3 listed)
- Uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Unwilling or unable to follow protocol requirements or provide consent.
- Any condition which in the Investigator's opinion deems the subject an unsuitable candidate to undergo imaging procedure.
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 ImagingUndergo PAI | Procedure or surgery | Diagnostic (photoacoustic imaging) |
Primary outcome
Feasibility of photoacoustic imaging (PAI) to quantify tumor characteristics
Time frame: Up to 6 months
This will be deemed a success if at least 3 imaging sessions produce a usable image. Usable datasets will be defined as those images with detectable PAI signal with minimal or no artifacts within the region of interest. This analysis will be done in the imaged sample, consisting of enrolled patients who attempt at least one imaging session. Patients who do not attempt at least one imaging session will be replaced.
4 secondary outcomes
Utility of serial PAI measurements
Time frame: Up to 6 months
Serial PAI oxygenation measurements
Time frame: Up to 6 months
Serial PAI oxygenation measurements
Time frame: Up to 6 months
Serial PAI oxygenation measurements
Time frame: Up to 6 months
Results and safety
The study was stopped early (reason given: Diagnostic issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
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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.
Anurag Singh principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photoacoustic Imaging in people with Breast Carcinoma and Healthy Subject, run by Roswell Park Cancer Institute at 1 site in United States.
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 11 inclusion and 3 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: stopped early, as of the sponsor's last update on 31 Mar 2023. 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 States. 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?
The study was stopped early (reason given: Diagnostic issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of photoacoustic imaging (PAI) to quantify tumor characteristics (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2023.