Multimodal Monitoring of Radiotherapy Response in Squamou... | NCT02379039

Studies
Multimodal Monitoring of Radiotherapy Response in Squamous Cell Cancer

NCT02379039

Sponsor

Umeå University

Status

Completed

Last Update Posted

Dec 22, 2023Actual

Enrollment

118Actual

Phase

Not provided

Conditions

Squamous Carcinoma
Head and Neck Cancer
Anal Cancer
Lung Cancer
Esophageal Cancer
Cervix Cancer

Interventions

Not provided

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015

Primary Completion Date

May 2023Actual

Completion Date

May 2023Actual

First Submitted Date

Feb 26, 2015

First Submission Date that Met QC Criteria

Mar 3, 2015

First Posted Date

Mar 4, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 21, 2023

Last Update Posted Date

Dec 22, 2023Actual

Name	Class
Lund University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study's aim is to define imaging and molecular bio-markers for prediction of radiotherapy response of squamous cell carcinomas, in an early treatment phase.

Detailed Description

Patients with squamous cell carcinoma of the head & neck, anal canal, cervix, esophagus or lung will be assessed before start of radiotherapy and 1-2 weeks after start. Multi-parametric MRI and 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (18F-FDG) positron emission tomography (PET) will be performed in parallel to metabolomic analyses of tumour tissue. The investigators will correlate changes in imaging bio-markers to corresponding changes in tissue or blood bio-markers by repeated imaging and biopsies for better understanding of the image parameters.

The data from the two assessments will be used for identifying imaging bio-markers, predictive for outcome. The patient data will be divided into one set of data for hypothesis generation and another set for validation.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

118Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Loco regional control	After completion of radiotherapy	2 years

Secondary Outcomes

Measure	Description	Time Frame
Loco regional tumour control (response)	After completion of radiotherapy	2 months
Patterns of failure	Time and location of recurrence

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Morphologically (pathology or cytology) verified, previously untreated squamous cell carcinoma (SCC) of the oral cavity, oropharynx, uterine cervix, oesophagus or lung.
The patient should be planned for treatment with radiotherapy alone or in combination with concomitant medical therapy
The tumour shall be radiologically and/or visually identifiable and accessible for biopsy without the need for general anaesthesia or other major interventions
The patient must be at least 18 years of age, able to understand the given information and, leave a written informed consent to participate

Exclusion Criteria:

The patient is unwilling to participate in the study
Patients with adjuvant post-operative radiotherapy (i.e. no visible remaining tumour)
Pregnancy or lactation
Contraindications to investigations with MRI, gadolinium contrast or PET-tracers
Patients with an estimated glomerular filtration rate (GFR) <60 ml/min/1.73m2.
Severe co-morbidities that are judged to significantly compromise survival in a two-years perspective.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with previously untreated squamous carcinoma aimed for radiotherapy with curative intent of the oral cavity, oropharynx, uterine cervix, oesophagus, anal canal or lung.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Björn Zackrisson, Professor	Umeå University, Department of Radiation Sciences - Oncology	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Umeå University		Umeå		SE-901 85	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38748271	Derived	Strandberg S, Jonsson J, Zarei M, Aglund K, Blomqvist L, Soderkvist K. Baseline and early response 2-[18F]FDG-PET/MRI for prediction of radiotherapy outcome in uterine cervical squamous cell carcinoma: a prospective single-center observational cohort study. EJNMMI Rep. 2024 Mar 1;8(1):5. doi: 10.1186/s41824-024-00188-7.

ID	Term
D002294	Carcinoma, Squamous Cell
D006258	Head and Neck Neoplasms
D001005	Anus Neoplasms
D008175	Lung Neoplasms
D004938	Esophageal Neoplasms
D002583	Uterine Cervical Neoplasms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms