Melanoma SPIO-MRI trial

JRCT ID: jRCTs051180047

Registered date:05/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Malignant melanoma
• Date of first enrollment: 23/02/2018
• Target sample size: 20
• Study type: Interventional

Intervention(s)

Identify the sentinel node by contrast-enhanced CT
Diagnose sentinel node metastases by contrast-enhanced MRI
Correlate with histopathological findings

Outcome(s)

• Primary Outcome: Sensitivity
• Secondary Outcome: Specificity, accuracy,negative predictive value, positive predictive value, adverse event

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.primary malignant melanoma
2.sentinel node biopsy planned
3.Written informed consent

Exclude criteria

1.Contraindication of contrast agents
2.Pregnant, unwilling to practice contraception
3.Patients with serious complication
4.Doctor judges inappropriate

Related Information

• Primary Sponsor: Motomura Kazuyoshi
• Source(s) of Monetary Support: Meito Sangyo Co.,Ltd,Takeda Pharmaceutical Company, Limited,Daiichi Sankyo Company, Limited