UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052240 |
|---|---|
| Receipt number | R000059547 |
| Scientific Title | Evaluation of fluorescence intensity in head and neck cancer patients treated with photoimmunotherapy using near-infrared camera system, prospective observational study |
| Date of disclosure of the study information | 2023/09/19 |
| Last modified on | 2023/09/14 18:02:48 |
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Basic information
Public title
Evaluation of fluorescence intensity in head and neck cancer patients treated with photoimmunotherapy using near-infrared camera system
Acronym
PIT Quest study
Scientific Title
Evaluation of fluorescence intensity in head and neck cancer patients treated with photoimmunotherapy using near-infrared camera system, prospective observational study
Scientific Title:Acronym
PIT Quest study
Region
| Japan |
Condition
Condition
Patients with head and neck cancer who are scheduled to be treated with photoimmunotherapy are eligible.
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Using near-infrared camera system, we aim to evaluate the fluorescence intensity of head and neck cancer during photoimmunotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Successful fluorescence intensity imaging
Key secondary outcomes
Fluorescence intensity before and after light irradiation and during treatment, Localization in tumor before and after light irradiation and during treatment
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically and cytologically confirmed to be a malignant tumor.
2) The primary site of tumor is larynx, oropharynx, hypopharynx, nasopharynx, oral cavity, nasal sinus, or salivary gland.
3) The patient is planned to be treated with photoimmunotherapy.
4) The patient can read Japanese.
5) Have a smartphone (both iOS and Android) from which applications can be downloaded.
6) The patient has been fully informed and has given his/her written consent.
Key exclusion criteria
1) The primary site of tumor is other than larynx, oropharynx, hypopharynx, nasopharynx, oral cavity, nasal sinus, or salivary gland.
2) The patient's physician determines that the patient is not suitable to participate in this study.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Ryuichi |
| Middle name | |
| Last name | Hayashi |
Organization
National Cancer Center Hospital East
Division name
Head and Neck Surgery
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL
04-7133-1111
rhayashi@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Tanaka |
Organization
National Cancer Center Hospital East
Division name
Head and Neck Surgery
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan.
TEL
04-7133-1111
Homepage URL
hidetana@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Shimadzu Corporation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center East
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan.
Tel
04-7133-1111
irst@ncc.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective observational study.
Patients who visited our hospital between 09/16/2023 and 08/31/2024 and meet the selection criteria will be included.
Tumor fluorescence before, during, and after photoimmunotherapy will be analyzed using real-time fluorescence imaging.
Patient background, surgical findings, fluorescence findings, disease background, adverse events, and outcome will be managed in CRF.
Management information
Registered date
| 2023 | Year | 09 | Month | 19 | Day |
Last modified on
| 2023 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059547
