Squamous Cell CarcinomaNCT04685798

Optimized Diffusion-Weighted Imaging for the Evaluation of Post-Treatment Squamous Cell Carcinoma in the Neck: Comparative Study With FDG PET/CT

A study testing Diffusion-weighted imaging magnetic resonance imaging and FDG PET/CT in people with Squamous Cell Carcinoma, run by Washington University School of Medicine at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The investigators propose a longitudinal study evaluating post-treatment changes in patients with squamous cell carcinoma (SCC) of the neck using an innovative optimized diffusion-weighted imaging (DWI) pulse sequence to identify more accurately recurrent tumors as well as early non-responders to therapy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Squamous Cell Carcinoma
What is being tested?: Diffusion-weighted imaging magnetic resonance imaging and FDG PET/CT
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: 2 Sep 2020to 26 Sep 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Histologically-proven newly diagnosis or recurrence as indicated by tissue diagnosis of T3 or T4 squamous cell carcinoma of the head and neck
Must have had or be scheduled for standard-of-care surgical resection, radiation, and/or chemo-radiation of the diagnosed squamous cell carcinoma of the head and neck
At least 18 years of age
Patient must be able to understand and willing to sign a written informed consent document.

Who cannot join

Contraindications to MRI, including:
MRI-incompatible implantable devices
severe claustrophobia; and
Pregnant and/or breastfeeding, with women of childbearing potential having a negative urine or serum pregnancy test

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University School of Medicine
St Louis, Missouri, 63110

Other trials in United States

About this study

Conditions: Squamous Cell Carcinoma
Being tested: Diffusion-weighted imaging magnetic resonance imaging, FDG PET/CT
Medical subject headings: Carcinoma, Squamous Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Diffusion-weighted imaging magnetic resonance imagingDevice
Also called DWI MRI
The research MRI study of the head and neck will be performed on a Siemens 3T MRI Scanner system
FDG PET/CTDevice
Standard of care

Study groups in NCT04685798
Study group	Role	What they receive
DWI MRI + Standard of care FDG PET/CT	Experimental	-The patients will undergo an optimized research neck DWI MRI, up to 3 weeks post-treatment and then a standard-of-care 3-month post-treatment FDG PET/CT examination. Receives: Device: Diffusion-weighted imaging magnetic resonance imaging; Device: FDG PET/CT

What is being measured

The primary outcome is the main question the study is designed to answer.

Apparent Diffusion Coefficient Mean (ADCmean)
- ADC=measure of the magnitude of diffusion (of water molecules) within tissue
- The primary tumor, suspicious lesion, and/or area of post-treatment change will be identified in anatomical images \& then outlined in the ADC sequence, excluding areas of cystic change and necrosis. If there are multiple lesions, only the dominant lesion with the lowest ADC will be used for analysis
- A histogram analysis method will examine the distribution of ADC values within each region of interest (ROI)
- ADCmean will describe distribution of ADC measurements in tumor/non-tumor tissues \& independent sample t-test will compare ADC measurements between the 2 groups
Measured: 2-3 weeks post-standard of care treatment
Apparent Diffusion Coefficient Lowest Value in a Tumor (ADCmin)
- ADC=measure of the magnitude of diffusion (of water molecules) within tissue
- The primary tumor, suspicious lesion, and/or area of post-treatment change will be identified in anatomical images \& then outlined in the ADC sequence, excluding areas of cystic change and necrosis. If there are multiple lesions, only the dominant lesion with the lowest ADC will be used for analysis
- A histogram analysis method will examine the distribution of ADC values within each region of interest (ROI)
- ADCmin will describe distribution of ADC measurements in tumor/non-tumor tissues \& independent sample t-test will compare ADC measurements between the 2 groups
Measured: 2-3 weeks post-standard of care treatment

Secondary outcomes (1)

Number of Participants That Were Non-responders to Treatment on Both the DWI MRI and the Standard of Care FDG PET/CT
Measured: 2-3 weeks post-standard of care treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Sep 202026 Sep 2023

First posted28 Dec 2020
Study start2 Sep 2020
Primary completion26 Sep 2023
Study completion26 Sep 2023

Why it stopped: Low accrual

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Squamous Cell CarcinomaStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe 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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04685798
Sponsor's protocol ID: 201912072
Status last verified: Sep 2024
First submitted: 24 Nov 2020
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Squamous Cell Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimized Diffusion-Weighted Imaging for the Evaluation of Post-Treatment Squamous Cell Carcinoma in the Neck: Comparative Study With FDG PET/CT
ClinicalTrials.gov ID: NCT04685798
Acronym / sponsor ID: 201912072
Conditions: Squamous Cell Carcinoma
Study type: Interventional
Recruitment status: TerminatedReason stopped: Low accrual
Enrolment: 8 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Study start: 2 Sep 2020 (actual)
Primary completion: 26 Sep 2023 (actual)
Study completion: 26 Sep 2023 (actual)
First posted: 28 Dec 2020 (actual)
Results: Posted 19 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
DWI MRI + Standard of care FDG PET/CT	Experimental	Device: Diffusion-weighted imaging magnetic resonance imaging, Device: FDG PET/CT-The patients will undergo an optimized research neck DWI MRI, up to 3 weeks post-treatment and then a standard-of-care 3-month post-treatment FDG PET/CT examination.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Histologically-proven newly diagnosis or recurrence as indicated by tissue diagnosis of T3 or T4 squamous cell carcinoma of the head and neck
Must have had or be scheduled for standard-of-care surgical resection, radiation, and/or chemo-radiation of the diagnosed squamous cell carcinoma of the head and neck
At least 18 years of age
Patient must be able to understand and willing to sign a written informed consent document.

Key exclusion criteria (4 listed)

Contraindications to MRI, including:
Pregnant and/or breastfeeding, with women of childbearing potential having a negative urine or serum pregnancy test

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
Diffusion-weighted imaging magnetic resonance imagingAlso: DWI MRIThe research MRI study of the head and neck will be performed on a Siemens 3T MRI Scanner system	Device	DWI MRI + Standard of care FDG PET/CT
FDG PET/CTStandard of care	Device	DWI MRI + Standard of care FDG PET/CT

Primary outcome

Apparent Diffusion Coefficient Mean (ADCmean)
Time frame: 2-3 weeks post-standard of care treatment
* ADC=measure of the magnitude of diffusion (of water molecules) within tissue * The primary tumor, suspicious lesion, and/or area of post-treatment change will be identified in anatomical images \& then outlined in the ADC sequence, excluding areas of cystic change and necrosis. If there are multiple lesions, only the dominant lesion with the lowest ADC will be used for analysis * A histogram analysis method will examine the distribution of ADC values within each region of interest (ROI) * ADCmean will describe distribution of ADC measurements in tumor/non-tumor tissues \& independent sample t-test will compare ADC measurements between the 2 groups
Apparent Diffusion Coefficient Lowest Value in a Tumor (ADCmin)
Time frame: 2-3 weeks post-standard of care treatment
* ADC=measure of the magnitude of diffusion (of water molecules) within tissue * The primary tumor, suspicious lesion, and/or area of post-treatment change will be identified in anatomical images \& then outlined in the ADC sequence, excluding areas of cystic change and necrosis. If there are multiple lesions, only the dominant lesion with the lowest ADC will be used for analysis * A histogram analysis method will examine the distribution of ADC values within each region of interest (ROI) * ADCmin will describe distribution of ADC measurements in tumor/non-tumor tissues \& independent sample t-test will compare ADC measurements between the 2 groups

1 secondary outcome

Number of Participants That Were Non-responders to Treatment on Both the DWI MRI and the Standard of Care FDG PET/CT
Time frame: 2-3 weeks post-standard of care treatment

Results and safety

Results posted to the registry on 19 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DWI MRI + Standard of Care FDG PET/CT	8	6

Primary outcome: Apparent Diffusion Coefficient Mean (ADCmean)

Time frame: 2-3 weeks post-standard of care treatment. Mean (Standard Deviation). Unit: x 10-6 mm^2/s

Measure	DWI MRI + Standard of Care FDG PET/CT n = 1
Value	1.337 (NA)

Population analysed: Evaluable patients include those that received the DWI MRI and the standard of care FDG PET/CT, had measurable disease on imaging, and had tumor persistence/recurrence.

Primary outcome: Apparent Diffusion Coefficient Lowest Value in a Tumor (ADCmin)

Time frame: 2-3 weeks post-standard of care treatment. Number. Unit: x 10-6 mm^2/s

Measure	DWI MRI + Standard of Care FDG PET/CT n = 1
Value	1.007

Population analysed: Evaluable patients include those that received the DWI MRI and the standard of care FDG PET/CT, had measurable disease on imaging, and had tumor persistence/recurrence.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected from start of MRI through completion of MRI (approximately 3 hours). Adverse events were not collected for the standard of care FDG PET/CT.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DWI MRI + Standard of Care FDG PET/CT	0 of 8 (0%)	0 of 8 (0%)	3 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Squamous Cell Carcinoma

RecruitingPhase 2
CASCADE 2002: PROTECT Study, "PRObiotics to TrEat Anal preCancer Trial
HSIL, High Grade Squamous Intraepithelial Lesion, HPV-Related Squamous Cell Carcinoma
Not yet recruitingPhase 3
Circulating Tumor DNA MRD-Guided Adjuvant Therapy for Curatively Resected Locally Advanced Esophageal Squamous Cell Carcinoma
Esophageal Cancer
RecruitingPhase 2
BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
RecruitingPhase 3
A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)
Non-small Cell Lung Cancer
RecruitingPhase 2
Biomarker Based Neoadjuvant Strategies for Locally Advanced Resectable ESCC
Esophageal Squamous Cell 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.

Gloria J Guzman Pérez-Carrillo, M.D. principal investigator

Washington University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 4 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 19 Sep 2024. 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?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Apparent Diffusion Coefficient Mean (ADCmean) (time frame: 2-3 weeks post-standard of care treatment). 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?

On the ClinicalTrials.gov record for NCT04685798.

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 19 Sep 2024.