Evaluation of safety and effectiveness of cryoablation in the treatment of TSC-AML

JRCT ID: jRCTs072200039

Registered date:01/10/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: renal angiomyolipoma associated with tuberous sclerosis
• Date of first enrollment: 06/10/2020
• Target sample size: 15
• Study type: Interventional
• Intervention(s): Cryotherapy will be performed after embolization for renal angiomyolipoma of greater than 1 cm and less than 4 cm.

Outcome(s)

• Primary Outcome: Disease control rate
• Secondary Outcome: Overall Response Rate, Safety, renal function, QOL, additional treatments

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.A patient over 16 years old at the time of obtaining consent
2.A patient with a definitive diagnosis of tuberous sclerosis according to the modified Gomez criteria or the TSC Clinical Consensus Guideline for Diagnosis 2012 at the time of registration
3.A patient with an independent AML on imaging within 4months before enrollment measuring greater than 1 cm and less than 4 cm in long axis as the treatment target, regardless of prsence or absence of mTOR inhibitor treatment
4.Informed consent has been obtained from one of the following:
1)The patient only (if the patient is over 20 years old and can fully understand the explanation)
2)The patient and his / her substitute (parent, guardian, etc.) (if the patient is under 20 years old and can fully understand the explanation)
3)Legal guardian only (if the patient is judged to lack the ability to make a decision regarding the conduct of the study)

Exclude criteria

1.A patient who cannot interrupt mTOR inhibitor treatment
2.A patient who cannot keep still during cryotherapy
3.A patient with platelets less than 6X10^4/uL(within 28 days before registration)
4.A patient with a history of serious allergies to contrast agents and / or embolic substances
5.A patient with infection requiring systemic treatment
6.A patient with malignant tumor
7.A woman who is pregnant, possibly pregnant or within 28 days after delivery
8.A patient who has a mental illness or psychiatric disorder that interferes with daily life, such that participation in the study is considered difficult
9.A patient with uncontrolled hypertension
10.A patient who is otherwise assessed as inappropriate by the doctor in charge

Related Information

• Primary Sponsor: Eto Masatoshi
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development