Mapping of Sentinel Lymph Node Drainage Using SPECT (SUSP... | NCT02572661

Studies
Mapping of Sentinel Lymph Node Drainage Using SPECT (SUSPECT) (SUSPECT)

NCT02572661

Sponsor

The Netherlands Cancer Institute

Status

Completed

Last Update Posted

Jun 27, 2019Actual

Enrollment

61Actual

Phase

Not Applicable

Conditions

Head and Neck Cancer

Interventions

radiation in Squamous Head and Neck Cancer

Countries

Netherlands

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

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
N14SUS	Registry Identifier	PTC
NL51706.031.14	Registry Identifier	CCMO

Status Module

Record Verification Date

Jun 2019

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

Jul 23, 2015Actual

Primary Completion Date

Nov 9, 2018Actual

Completion Date

Nov 9, 2018Actual

First Submitted Date

Dec 22, 2014

First Submission Date that Met QC Criteria

Oct 8, 2015

First Posted Date

Oct 9, 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

Jun 26, 2019

Last Update Posted Date

Jun 27, 2019Actual

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

This study aims to explore the feasibility, safety and outcome of a non-invasive sentinel node mapping (SNM) to individually tailor the elective nodal irradiation (ENI) to the ipsilateral neck only and to exclude the contralateral negative neck from the irradiation fields when there is no draining sentinel node. Subsequently the dose to the salivary glands, mucosal area and the swallowing and chewing muscles and structures involved in voicing and articulation will significantly be reduced

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

61Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Squamous Head and Neck Cancer	Other	radiation	Radiation: radiation in Squamous Head and Neck Cancer

Interventions

Name	Type	Description	Arm Group Labels	Other Names
radiation in Squamous Head and Neck Cancer	Radiation		Squamous Head and Neck Cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Feasibility and safety of single side radiation therapy measured by physical examination and toxicity measurement by CTCAE 4.03 at 12 weeks	mapping of sentinel lymph node drainage to indentify groups at low risk of the probability of contra regionale failure is to be estimated to be 2% at 2 years. A recurrrence rate of >15% will be assumed unacceptable	12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Newly diagnosed patients with histopathologic proven primary HNSCC (T1 -3 N0 -1) located in the oral cavity, oropharynx, larynx (except T1 glottic ), and hypopharynx, not crossing the midline and planned for treatment with (chemo)radiotherapy in curative setting
No chemotherapy or surgery prior to inclusion
No distant metastatic spread at the time of inclusion
Age ≥ 18 years
WHO performance status 0 or 1
Signed written informed consent

Exclusion Criteria:

Patients with previously radiation treatment in the head and neck region, for any reason
Patients with previous neck dissection
Patients with recurrent or second primary tumor in the head and neck region
Patients with head and neck malignancies arising from skin, lip, nose, sinuses, nasopharynx, salivary glands, thyroid gland or esophagus
Previous history of cancer in the last five years (excluding basal cell carcinoma of the skin and in situ SCC of the cervix)
Pregnancy or no active contraception for pre-menopausal women
Known hypersensitivity to iodine or nanocolloid injection
Having any condition (physical, mental, sociological) that interferes with the informed consent procedure and follow up schedules

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

Not provided

Sampling Method

Not provided

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms