Head and Neck CarcinomaNCT04110249
Photoacoustic Imaging for Measuring Tumors and Normal Tissue in Patients With Head and Neck Cancer
A study testing Photoacoustic Imaging and Transcutaneous Acupoint Electrical Stimulation in people with Head and Neck Carcinoma and Head and Neck Lymph Node, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This trial studies how well photoacoustic imaging works in measuring tumors and normal tissue in patients with head and neck cancer. Photoacoustic imaging (PAI) is a low-risk imaging method that provides information about the oxygenation of tissues using a combination of light and ultrasound techniques. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Carcinoma, Head and Neck Lymph Node, Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Photoacoustic Imaging and Transcutaneous Acupoint Electrical Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2019to 29 Dec 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- FOR CANCER PATIENTS IN THE H\&N RADIATION GROUP (PART I):
- Biopsy-confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) getting chemoradiation therapy
- Presence of neck nodes or laryngeal tumor superficial enough (within 2-3 cm of skin surface) to allow imaging by photoacoustic ultrasound (PA-US)
- FOR ALTENS PATIENTS (PART II):
- History of prior radiation therapy with xerostomia requiring ALTENS
Who cannot join
- Uncontrolled intercurrent 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) in H&Amp;N Cancer Patients
This trial studies how well photoacoustic imaging works in measuring tumors and normal tissue in patients with head and neck cancer. Photoacoustic imaging (PAI) is a low-risk imaging method that provides information about the oxygenation of tissues using a combination of light and ultrasound techniques. This study may help doctors determine if PAI is correlated with clinical responses of both tumor (for example: shrinking, swelling or disappearing) and normal tissues (for example: skin redness, dry mouth, appearance of sores, healing of skin or mucosa). If there is a correlation with clinical responses, then doctors may develop PAI as method for measuring response to earlier treatment.
Read the detailed description
PRIMARY OBJECTIVE:
- Define the feasibility of the current photoacoustic imaging (PAI) technology in head and neck (H\&N) cancer patients.
SECONDARY OBJECTIVE:
- Define the utility of the current PAI in H\&N cancer patients.
OUTLINE:
PART I: Patients undergo PAI before the start of chemoradiation therapy, weekly during 7 weeks of chemoradiation, and again 3-4 months after completion of chemoradiation therapy.
PART II (CANCER-FREE WITH XEROSTOMIA): Patients undergo PAI at baseline, up to twice during acupuncture-like transcutaneous nerve stimulation (ALTENS) therapy, once after ALTENS, and at 3-6 months follow up.
- Conditions
- Head and Neck Carcinoma, Head and Neck Lymph Node, Head and Neck Squamous Cell Carcinoma, Laryngeal Neoplasm, Radiation Therapy Recipient
- Being tested
- Photoacoustic Imaging, Transcutaneous Acupoint Electrical Stimulation
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Laryngeal Neoplasms
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
Transcutaneous Acupoint Electrical StimulationProcedure or surgery
Also called acupuncture-like transcutaneous electrical nerve stimulation, ALTENS, TAES
Undergo ALTENS
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (PAI, ALTENS) | Experimental | PART I: Patients undergo PAI before the start of chemoradiation therapy, weekly during 7 weeks of chemoradiation, and again 3-4 months after completion of chemoradiation therapy.
PART II (CANCER-FREE WITH XEROSTOMIA): Patients undergo PAI at baseline, up to twice during acupuncture-like transcutaneous nerve stimulation (ALTENS) therapy, once after ALTENS, and at 3-6 months follow up. Receives: Procedure: Photoacoustic Imaging; Procedure: Transcutaneous Acupoint Electrical Stimulation |
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 (part I): rate
Feasibility rate is defined as the proportion of evaluable patients who have at least 3 imaging sessions that produce a usable image.
Measured: Up to 6 months after treatment completion
Feasibility of PAI to quantify tumor characteristic in patients undergoing ALTENS (part II): rate
Feasibility rate is defined as the proportion of evaluable patients who have at least 3 imaging sessions that produce a usable image.
Measured: Up to 2 years
Secondary outcomes (2)
Utility of serial PAI-based oxygen saturation (%sO2) measurements
Descriptive statistics (means, medium) will be used to summarize percent of SO2
Measured: Up to 2 years
Changes in hemoglobin (hbt) measurements
Compare hemoglobin measurements between baseline until end of study
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start6 Sep 2019
- Primary completion29 Dec 2022
- Study completion29 Dec 2022
Why it stopped: equipment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck 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
- 14 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 K Singh, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04110249
- Sponsor's protocol ID
- I 48917
- Other IDs
- NCI-2019-06045, I 48917, P30CA016056, R01CA204636
- Status last verified
- Apr 2023
- First submitted
- 24 Sep 2019
- Last updated
- 10 Apr 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 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Photoacoustic Imaging (PAI) in H&Amp;N Cancer Patients
- ClinicalTrials.gov ID
- NCT04110249
- Acronym / sponsor ID
- I 48917
- Conditions
- Head and Neck Carcinoma, Head and Neck Lymph Node, Head and Neck Squamous Cell Carcinoma, Laryngeal Neoplasm, Radiation Therapy Recipient
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: equipment issues
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 Sep 2019 (actual)
- Primary completion
- 29 Dec 2022 (actual)
- Study completion
- 29 Dec 2022 (actual)
- First posted
- 1 Oct 2019 (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 trial studies how well photoacoustic imaging works in measuring tumors and normal tissue in patients with head and neck cancer. Photoacoustic imaging (PAI) is a low-risk imaging method that provides information about the oxygenation of tissues using a combination of light and ultrasound techniques. This study may help doctors determine if PAI is correlated with clinical responses of both tumor (for example: shrinking, swelling or disappearing) and normal tissues (for example: skin redness, dry mouth, appearance of sores, healing of skin or mucosa). If there is a correlation with clinical responses, then doctors may develop PAI as method for measuring response to earlier treatment.
Detailed description
PRIMARY OBJECTIVE:
- Define the feasibility of the current photoacoustic imaging (PAI) technology in head and neck (H\&N) cancer patients.
SECONDARY OBJECTIVE:
- Define the utility of the current PAI in H\&N cancer patients.
OUTLINE:
PART I: Patients undergo PAI before the start of chemoradiation therapy, weekly during 7 weeks of chemoradiation, and again 3-4 months after completion of chemoradiation therapy.
PART II (CANCER-FREE WITH XEROSTOMIA): Patients undergo PAI at baseline, up to twice during acupuncture-like transcutaneous nerve stimulation (ALTENS) therapy, once after ALTENS, and at 3-6 months follow up.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (PAI, ALTENS) | Experimental | Procedure: Photoacoustic Imaging, Procedure: Transcutaneous Acupoint Electrical StimulationPART I: Patients undergo PAI before the start of chemoradiation therapy, weekly during 7 weeks of chemoradiation, and again 3-4 months after completion of chemoradiation therapy. PART II (CANCER-FREE WITH XEROSTOMIA): Patients undergo PAI at baseline, up to twice during acupuncture-like transcutaneous nerve stimulation (ALTENS) therapy, once after ALTENS, and at 3-6 months follow up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- FOR CANCER PATIENTS IN THE H\&N RADIATION GROUP (PART I):
- Biopsy-confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) getting chemoradiation therapy
- Presence of neck nodes or laryngeal tumor superficial enough (within 2-3 cm of skin surface) to allow imaging by photoacoustic ultrasound (PA-US)
Key exclusion criteria (3 listed)
- Uncontrolled intercurrent 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 (PAI, ALTENS) |
| Transcutaneous Acupoint Electrical StimulationAlso: acupuncture-like transcutaneous electrical nerve stimulation, ALTENS, TAESUndergo ALTENS | Procedure or surgery | Diagnostic (PAI, ALTENS) |
Primary outcome
Feasibility of photoacoustic imaging (PAI) to quantify tumor characteristics (part I): rate
Time frame: Up to 6 months after treatment completion
Feasibility rate is defined as the proportion of evaluable patients who have at least 3 imaging sessions that produce a usable image.
Feasibility of PAI to quantify tumor characteristic in patients undergoing ALTENS (part II): rate
Time frame: Up to 2 years
Feasibility rate is defined as the proportion of evaluable patients who have at least 3 imaging sessions that produce a usable image.
2 secondary outcomes
Utility of serial PAI-based oxygen saturation (%sO2) measurements
Time frame: Up to 2 years
Changes in hemoglobin (hbt) measurements
Time frame: Up to 2 years
Results and safety
The study was stopped early (reason given: equipment issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
Related trials for Head and Neck Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
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 K 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 and Transcutaneous Acupoint Electrical Stimulation in people with Head and Neck Carcinoma and Head and Neck Lymph Node, 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 7 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 10 Apr 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: equipment 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 (part I): rate (time frame: Up to 6 months after treatment completion). The study lists 2 primary outcomes in all. 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 10 Apr 2023.