NCT03630601

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 28, 2018

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2023

Completed
Last Updated

March 31, 2023

Status Verified

March 1, 2023

Enrollment Period

4.7 years

First QC Date

July 24, 2018

Last Update Submit

March 29, 2023

Conditions

Breast CarcinomaHealthy SubjectMalignant Soft Tissue NeoplasmSarcomaSkin Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 6 months

Secondary Outcomes (4)

  • Utility of serial PAI measurements

    Up to 6 months

  • Serial PAI oxygenation measurements

    Up to 6 months

  • Serial PAI oxygenation measurements

    Up to 6 months

  • Serial PAI oxygenation measurements

    Up to 6 months

Study Arms (1)

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.

Procedure: Photoacoustic Imaging

Interventions

Photoacoustic ImagingPROCEDURE

Undergo PAI

Diagnostic (photoacoustic imaging)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsSarcoma

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplasms, Connective and Soft TissueNeoplasms by Histologic Type

Study Officials

  • Anurag Singh

    Roswell Park Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2018

First Posted

August 15, 2018

Study Start

June 28, 2018

Primary Completion

March 15, 2023

Study Completion

March 15, 2023

Last Updated

March 31, 2023

Record last verified: 2023-03

Locations

US(1)