NCT03908684Toboroz
Ultrasound Spectroscopy as Early Indicators of Radiation Treatment Response in Prostate, Rectum and Head & Neck Cancers
Pilot Investigation of Ultrasound Cell Death Imaging and Spectroscopy as Early Indicators of Response to Radiation Treatment in Prostate, Rectum and Head and Neck Cancers, and to Characterize Prostate Masses
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2023. dec. 13. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
Our objective in this study is to identify an optimal ultrasound spectroscopy parameter that can be used as an early predictor of pathological complete or partial response in men with prostate cancer and men and women with rectum and head and neck cancers receiving treatment radiotherapy. We have previously demonstrated that high-frequency ultrasound and spectroscopy, and recently conventional-frequency ultrasound and spectroscopy may be used to detect cell death in vitro, in situ and in vivo. The method can detect different forms of cell death and has been demonstrated to be sensitive to apoptotic, necrotic and mitotic cell death. The main goal, as described above, is to select the best ultrasound spectroscopy parameter to use as an early predictor of pathological complete response
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 320 (tervezett)
- Első benyújtás
- 2019. ápr. 8.
- Kezdés
- 2014. dec. 17.
- Elsődleges befejezés
- 2025. dec. 17.
- Fő szponzor
- Sunnybrook Health Sciences Centre
- Betegségek
- Gyermekkori daganatok, Prosztatarák, Fej-nyaki daganatok, Vastagbélrák
- NCT-szám
- NCT03908684
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 320
- 2014. dec. 17. és az elsődleges befejezés (2025. dec. 17.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- (1) Chemotherapy, radiotherapy, or major surgery within 4 weeks prior to registering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks prior to registration
- (2) Receiving any other investigational agents
- (5) Contraindications to radiotherapy such as but not limited to:
- (i) previous radiotherapy to an involved area (ii) active collagen vascular disease (iii) genetic diseases associated with hyper-radiosensitivity
Más betegség
- (4) History of allergic reactions attributed to compounds of similar chemical or biologic composition
- (6) Any clinically serious infections requiring systemic anti-bacterial, antifungal or antiviral therapy
- (7) Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, and cardiac arrhythmia
- (8) Psychiatric illness/social situations that would limit compliance with study requirements
- (9) History of active ongoing seizure disorder, substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- (10) Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
Egyéb
- (3) Known brain metastases
Kiket keres a vizsgálat
- (1) Histologically or cytologically confirmed prostate, rectum and head and neck carcinoma which has not been treated with any first-line therapy and will be treated with radiation therapy
- (2) Measurable disease by ultrasound, or MRI performed within 28 days prior to treatment
- (3) Eastern Co-operative Oncology Group (ECOG) Performance Status of 0 or 1
- (4) Life expectancy of at least 6 months
- (5) Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to dosing:
- (i) hemoglobin >90 mg/dL (ii) leukocytes >3,000/mL (iii) absolute neutrophil count >1,500/mL (iv) platelets >100,000/mL (v) total bilirubin within normal institutional limits (vi) AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal (vii) creatinine within normal institutional limits or creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional upper limit of normal
- (6) Patients should have the ability to understand and the willingness to sign a written informed consent document. Signed informed consent must be obtained prior to any study specific procedures
Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Sunnybrook Health Sciences Centre | Toronto | Kanada | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.