FAMT-PET for lymphoma

JRCT ID: jRCTs031180300

Registered date:15/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Malignant lymphoma
• Date of first enrollment: 19/04/2017
• Target sample size: 80
• Study type: Interventional
• Intervention(s): 18F-FAMT-PET performed on pre-and mid-treatment

Outcome(s)

• Primary Outcome: The relationship between the disappearance of 18F-FAMT and response to treatment

Secondary Outcome

1)Comparison of detection of lesion between 18F-FAMT-PET and CT or 18F-FDG-PET imaging
2)Incidence, nature, and severity of of adverse event

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)20 years of age or older
2)untreated malignant lymphoma
3)Eastern Cooperetive Oncology Group (ECOG) Performance status (PS) 0-2
4)Measurable disease
5)Adequate organ function
6)Written informed consent

Exclude criteria

1)Pregnant, unwilling to practice contraception during the study or lactating female
2)Active infection
3)Multiple primary cancers with disease-free period less than 5 years, except carcinoma in situ or intra mucosal disease cured by local therapy
4)systemic steroid or immunosuppressant administration
5)pulmonary injury
6)Unfit patients judged by doctors

Related Information

• Primary Sponsor: Tsukamoto Norifumi
• Source(s) of Monetary Support: Kyowa Hakko Kirin Co., Ltd.,Astellas Pharma,Chugai Pharmaceutical Co., Ltd.
• Secondary ID(s): UMIN000025980