Study on Classification Method of Indocyanine Green Lymphography Based on Deep Learning

NCT ID: NCT04824378

Last Updated: 2021-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-01

Study Completion Date

2022-10-01

Brief Summary

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Breast cancer related lymphedema (BCRL) is the most common complication after breast cancer surgery, which brings a heavy psychological and spiritual burden to patients. For a long time, the diagnosis and treatment of lymphedema has been a difficult point in domestic and foreign research. To a large extent, it is because most of the patients who come to see a doctor have already developed obvious lymphedema, and the internal lymphatic vessels have undergone pathological remodeling\[1\] Therefore, it is particularly important to detect early lymphedema and intervene in time through the use of sensitive screening tools. Indocyanine green (ICG) lymphangiography is a relatively new method, which can display superficial lymph flow in real time and quickly, and will not be affected by radioactivity \[7\]. In 2007, indocyanine green lymphography was used for the first time to evaluate the function of superficial lymphatic vessels. In 2011, Japanese scholars found skin reflux signs based on ICG lymphography data of 20 patients with lymphedema after breast cancer surgery, and they were roughly divided into three types according to their severity: splash, star cluster, and diffuse (Figure 1) \[8\]. Later, in 2016, a prospective study involving 196 people affirmed the value of ICG lymphography in the early diagnosis of lymphedema, and made the images of ICG lymphography more specific stages 0-5 \[9\], but The staging is still based on the three types of skin reflux symptoms found in a small sample clinical study in 2011, which is not completely applicable in actual clinical applications. In addition, when abnormal skin reflux symptoms appear on ICG lymphangiography, the pathophysiological changes that occur in the body lack research and exploration. Therefore, this research hopes to refine the image features of ICG lymphography through machine learning (deep learning), and establish a PKUPH model for diagnosing early lymphedema by staging the image features.

Detailed Description

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Conditions

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Breast Cancer Related Lymphedema Deep Learning

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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label 1

Baseline data measurement of this group of patients: arm circumference(positive) and ICG (positive).

No Intervention.

Intervention Type OTHER

No Intervention.Only learn ICG image features of different label groups

label 2

Baseline data measurement of this group of patients: arm circumference(negative) and ICG (positive).

No Intervention.

Intervention Type OTHER

No Intervention.Only learn ICG image features of different label groups

label 3

Baseline data measurement of this group of patients: arm circumference(negative) and ICG (negative).

No Intervention.

Intervention Type OTHER

No Intervention.Only learn ICG image features of different label groups

Interventions

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No Intervention.

No Intervention.Only learn ICG image features of different label groups

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* From October 2016 to present, about 200 patients who have been admitted to the Breast Surgery Clinic due to the main complaint of upper extremity edema, are willing to accept ICG lymphography, arm circumference measurement, drainage measurement, bioelectrical impedance measurement, main complaint scale, etc. .

Exclusion Criteria

* Bilateral breast cancer; history of contrast agent allergy; arteriovenous thrombosis in the affected limb; regional lymph node recurrence; no informed consent; severe heart and brain diseases; primary lymphatic system disease (such as lymphatic leakage); unilateral only The limbs received ICG imaging.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shu Wang, Dr

Role: PRINCIPAL_INVESTIGATOR

Breast Center, Peking University People's Hospital, Beijing, China

Locations

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Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Siyao Liu, Dr

Role: CONTACT

+8618801229921

Facility Contacts

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liu siyao

Role: primary

+86 18801229921

References

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Beek MA, te Slaa A, van der Laan L, Mulder PG, Rutten HJ, Voogd AC, Luiten EJ, Gobardhan PD. Reliability of the Inverse Water Volumetry Method to Measure the Volume of the Upper Limb. Lymphat Res Biol. 2015 Jun;13(2):126-30. doi: 10.1089/lrb.2015.0011.

Reference Type BACKGROUND
PMID: 26091408 (View on PubMed)

Shi S, Lu Q, Fu MR, Ouyang Q, Liu C, Lv J, Wang Y. Psychometric properties of the Breast Cancer and Lymphedema Symptom Experience Index: The Chinese version. Eur J Oncol Nurs. 2016 Feb;20:10-6. doi: 10.1016/j.ejon.2015.05.002. Epub 2015 Jun 9.

Reference Type BACKGROUND
PMID: 26071198 (View on PubMed)

Mihara M, Hara H, Araki J, Kikuchi K, Narushima M, Yamamoto T, Iida T, Yoshimatsu H, Murai N, Mitsui K, Okitsu T, Koshima I. Indocyanine green (ICG) lymphography is superior to lymphoscintigraphy for diagnostic imaging of early lymphedema of the upper limbs. PLoS One. 2012;7(6):e38182. doi: 10.1371/journal.pone.0038182. Epub 2012 Jun 4.

Reference Type BACKGROUND
PMID: 22675520 (View on PubMed)

Yamamoto T, Yamamoto N, Doi K, Oshima A, Yoshimatsu H, Todokoro T, Ogata F, Mihara M, Narushima M, Iida T, Koshima I. Indocyanine green-enhanced lymphography for upper extremity lymphedema: a novel severity staging system using dermal backflow patterns. Plast Reconstr Surg. 2011 Oct;128(4):941-947. doi: 10.1097/PRS.0b013e3182268cd9.

Reference Type BACKGROUND
PMID: 21681123 (View on PubMed)

Other Identifiers

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PKUPH202102

Identifier Type: -

Identifier Source: org_study_id

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