NL-OMON55517尚未招募不适用
Image-guided targeted doxorubicin delivery with hyperthermia to optimize loco-regional control in breast cancer; the i-GO feasibility study. Phase I Feasibility Study of High-Intensity Focused Ultrasound-Induced Hyperthermia, Lyso-Thermosensitive Liposomal Doxotubicin for Metastatic Breast Cancer - i-GO feasibility study
niversitair Medisch Centrum Utrecht0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients must meet all of the following inclusion criteria:
- •1. Histologically confirmed adenocarcinoma of the breast and planned for
- •palliative chemotherapy with doxorubicine monotherapy or combination therapy
- •with cyclophosphamide
- •2. Biopsy-proven stage T1-4c2AnyNM1 at the diagnosis of breast cancer.
- •3. Non-pregnant, non-lactating female at least 18 years of age. If patient is
- •child-bearing age, she must have a negative serum pregnancy test prior to
- •enrollment and must agree to practice an acceptable form of birth control while
- •4. The tumor is located within the reach of the HIFU beam (based on
- •pre-treatment DCE-MRI findings).
- •5. The target breast is expected to fit in the cup of the dedicated MR-HIFU
- •breast system (based on pre-treatment MRI findings).
- •6. The patient weighs less than 90 kg (restrictment of the HIFU table top).
- •7. Provide written informed consent and willing to comply with protocol
- •requirements.
排除标准
- •Patients will be excluded if any of the following conditions are observed:
- •1. HER2-positive disease or classic invasive lobular carcinoma (ILC).
- •2. A treatment plan with curative intent is available.
- •3. Progression under prior therapy with antracyclines or other indications that
- •anthracycline-resistance may be present
- •4. Prior treatment with anthracyclines exceeding a maximum dose of 240 mg/m2
- •5. No measurable disease at baseline (according to RECIST 1.1 or PERCIST 1.0)
- •6. Any concomitant malignancy
- •7. Prior sensitivity (including rash, dyspnea, wheezing, urticarial, or other
- •symptoms) attributed to any liposomal-encapsulated drug.
- •8. Baseline laboratory valuesies:
- •ANC**************. < 1.5 x 10^9/L
- •Platelets ************... < 75 x 10^9/L
- •Hemoglobin ***********. < 5.6 mmol/L (9 g/dl)
- •Total Bilirubin **********. > 1.5X upper limit of normal
- •(in our hospital >32 µmol/L)
- •ALAT and ASAT **********. > 2.5X upper limit of normal (in our hospital >88U/L
- •and >75U/L respectively)
- •> 5X upper limit of normal in case of liver metastases
- •eGFR < 30 ml/min/1.73m2
- •9. World Health Organization Performance Status (WHO-PS) >2.
- •10. Left Ventricular Ejection Fraction <50% (validated by baseline scan).
- •11. History of:
- •a. Acute coronary syndrome in the last year
- •b. Cerebral vascular accident in the last year
- •c. Abnormal cardiac stress testing within last 6 months
- •d. Symptomatic coronary artery disease
- •e. Uncontrolled hypertension or cardiomyopathy
- •f. Cardiac valvular surgery or open heart surgery in the last year
- •g. Known structural heart disease
- •12. Any condition which may interfere with the hyperthermia portion of the
- •trial such as: functioning cardiac pacemaker; metal plates, rods or prosthesis
- •of the chest wall, breast prosthesis in the treated breast, severe numbness
- •and/or tingling of the chest wall or breast, skin grafts and/or flaps on the
- •breast or chest wall, scar tissue or surgical clips in the HIFU beam path.
- •13. Active infection
- •14. Body temperature > 38.0 degrees Celsius on the day of a MR-HIFU treatment.
- •15. Concurrent use of any of the following prohibited medications within a
- •reasonable wash-out time: protease inhibitors, cyclosporine, carbamazepine,
- •phenytoin, valproic acid, paclitaxel, trastuzumab and other liposomal drugs
- •(AbelectTM, Ambisome*, NyotranTM, etc.) or lipid-complexed drugs.
- •16. Caution will be exercised with all the medications mentioned in appendix C
- •of the study protocol, for interactions are theoretically possible.
- •17. Contraindications to MR imaging (e.g., pacemaker in situ, severe
- •claustrophobia, metal implants incompatible with the MRI-scan, body size
- •incompatible with MR bore).
- •18. Contraindications to gadolinium-based contrast agent and the tumor is not
- •sufficiently visible on MRI without contrast (including prior allergic reaction
- •to gadolinium-based contrast agent, and/or renal failure).
- •19. Contraindications to sedation and analgesia with propofol and Remifentanil,
- 另有 6 项未显示
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