Clinical Trial Results:
The intraoperative use of fluorescent tracers and multimodal imaging techniques in treatment of head and neck cancer
Summary
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EudraCT number |
2013-003578-28 |
Trial protocol |
DK |
Global end of trial date |
20 Jan 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
27 May 2018
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First version publication date |
27 May 2018
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Other versions |
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Summary report(s) |
Study 1 Study 2 - Study repport |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
2013070001
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Rigshospitalet
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Sponsor organisation address |
Blegdamsvej 9, Copenhagen, Denmark, 2100
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Public contact |
Department of Clinical Clinical Physiology, Nuclear Medine & PET , Rigshospitalet, 0045 35454216, andreas.kjaer@regionh.dk
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Scientific contact |
Department of Clinical Clinical Physiology, Nuclear Medine & PET , Rigshospitalet, 0045 35454216, andreas.kjaer@regionh.dk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
08 Mar 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
20 Jan 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
20 Jan 2017
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To examine and implement the intraoperative use of fluorescent tracers and optical imaging in the treatment of oral cancer.
Study 1: Near-infrared Fluorescence Tracer Imaging in sentinel Node Biopsi for oral cavity cancer patients
Study 2: Near-infrared Fluorescence assisted neck dissection in oral cancer
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Protection of trial subjects |
I accordance with national ethical approval
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Oct 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 61
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Worldwide total number of subjects |
61
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EEA total number of subjects |
61
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
41
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From 65 to 84 years |
20
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85 years and over |
0
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Recruitment
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Recruitment details |
Patients with primary oral cancer referred to Rigshospitalet for surgery as first treatment modality Study 1: Patients planed for SNB-staging surgery Study 2: Patients planed for therapeutic neck dissction | ||||||||||||
Pre-assignment
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Screening details |
Histology verified squamous cell carcinoma of the oral cavity CT and/or MRI og the neck | ||||||||||||
Period 1
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Period 1 title |
over-all trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | ||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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NIRF-Neck | ||||||||||||
Arm description |
Study 2: Arm 1: NIR-Fluorescence-guided neck dissection | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Indocyanine Green
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for solution for injection/infusion
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Routes of administration |
Soft tissue use
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Dosage and administration details |
Study 1: 0,05 mg ICG
STudy 2: 0,2 mg ICG
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Arm title
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Conventional neck dissection | ||||||||||||
Arm description |
Study 2 Arm 2: Cenventional neck dissection | ||||||||||||
Arm type |
conventional surgery | ||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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Study 1 - NIRF-SNB | ||||||||||||
Arm description |
One arm study | ||||||||||||
Arm type |
Feasibility - no control arm | ||||||||||||
Investigational medicinal product name |
Indocyanine Green
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for solution for injection/infusion
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Routes of administration |
Soft tissue use
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Dosage and administration details |
Study 1: 0,05 mg ICG
STudy 2: 0,2 mg ICG
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Baseline characteristics reporting groups
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Reporting group title |
over-all trial
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
NIRF-Neck
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Reporting group description |
Study 2: Arm 1: NIR-Fluorescence-guided neck dissection | ||
Reporting group title |
Conventional neck dissection
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Reporting group description |
Study 2 Arm 2: Cenventional neck dissection | ||
Reporting group title |
Study 1 - NIRF-SNB
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Reporting group description |
One arm study |
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End point title |
Study 1: Additional sentinel nodes identified by NIRF-guidance. [1] [2] | ||||||
End point description |
Study 1:
Additional sentinel nodes only identified due to the additional use of NIR fluorescence intraoperatively
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End point type |
Primary
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End point timeframe |
post-surgery
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The endpoint in study 1 is additional sentinel lymph nodes identified due to use of NIRF imaging - no analysis kan be presented apart from a numerical number. [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint in study 1 is additional sentinel lymph nodes identified due to use of NIRF imaging - no analysis kan be presented apart from a numerical number. |
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No statistical analyses for this end point |
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End point title |
Study 2: Number of lymph nodes in the neck dissecion specimen from level Ib-III [3] [4] | |||||||||
End point description |
study 2:
Number of lymph nodes harvested in the neck dissecion specimen in level Ib-III
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End point type |
Primary
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End point timeframe |
post-operatively
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Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The endpoint in study 2 is simple the number of harvested lymph nodes in the control Group vs. the NIRF-Neck Group. The stastistics is reported in the attachment report. [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is simple the number of harvested lymph nodes in the control Group vs. the NIRF-Neck Group. The stastistics is reported in the attachment report. |
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Notes [5] - 16 patients and 17 neck-sides for analysis [6] - 15 patients and 17 neck sides for evaluation |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
From time of injection of tracer substance to two weeks post-surgery
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Adverse event reporting additional description |
No adverse events was recorded
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
clinical examination | ||
Dictionary version |
1
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Frequency threshold for reporting non-serious adverse events: 0% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No adverse events was seen. |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/26467454 |