NCT05047913Fut, nem toborozKorai 1. fázis
Comprehensive Evaluation of Tumor Oxygenation, Metabolism and Blood Supply of High Grade Glioma and Cervical Cancers Using Dynamic FAZA PET and Multiparametric MR
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 8.
Rövid összefoglaló (regiszter, angolul)
Primary Objectives To investigate the relationship between dynamic MRI, brain tumor perfusion (DSC) and permeability (DCE), and dynamic 18F-FAZA PET uptake. Secondary Objectives To investigate the relationship between tumors with greater hypoxia defined by qBOLD and 18F-FAZA PET and pathological features including proportionate necrosis, Ki-67 and IDH mutation status To investigate the correlation between the hypoxic tumor region delineated using 18F-FAZA PET and qBOLD
- Állapot (regiszter)
- Fut, nem toboroz
- Fázis (regiszter)
- Korai 1. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 20 (tervezett)
- Első benyújtás
- 2021. szept. 3.
- Kezdés
- 2021. szept. 20.
- Elsődleges befejezés
- 2027. febr. 2.
- Fő szponzor
- M.D. Anderson Cancer Center
- Betegségek
- Méhnyakrák
- NCT-szám
- NCT05047913
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · Korai 1. fázis
- Tervezett résztvevők: 20
- 2021. szept. 20. és az elsődleges befejezés (2027. febr. 2.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Prior nephrectomy or planned nephrectomy.
- Prior brain radiation within 30 days.
- Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the investigator may significantly interfere with study compliance.
- Cervical Cohort
- Prior nephrectomy or planned nephrectomy.
- Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the investigator may significantly interfere with study compliance.
Más betegség
- Subjects with contraindications to the use of 18F-FAZA including confirmed allergy.
- Subjects with contraindications to the use of 18F-FAZA including confirmed allergy.
Laborértékek
- Pregnant or lactating women: Pregnant women are excluded from this study because the effects of 18F-FAZA in pregnancy are not known. A urine or serum pregnancy test will be performed before enrollment after informed consent is obtained. The pregnancy test is part of SOC before imaging.
- Pregnant or lactating women: Pregnant women are excluded from this study because the effects of 18F-FAZA in pregnancy are not known. A urine or serum pregnancy test will be performed before enrollment after informed consent is obtained. The pregnancy test is part of SOC before imaging.
Egyéb
- Glioma Cohort
- Lactation should be suspended for at least two days following the administration of 18F-FAZA to the mother, because of the unknown but potential risk for adverse events in nursing infants secondary to administration of the radionuclide to a lactating woman.
- Patients with a body weight of 400 pounds or more, or a BMI which precludes their entry into the bore of the PET-MRI scanner, because the findings will probably be compromised in image quality with PET-MRI.
- Lactation should be suspended for at least two days following the administration of 18F-FAZA to the mother, because of the unknown but potential risk for adverse events in nursing infants secondary to administration of the radionuclide to a lactating woman.
- Patients with a body weight of 400 pounds or more, or a BMI which precludes their entry into the bore of the PET-MRI scanner, because the findings will probably be compromised in image quality with PET-MRI and MRI.
Kiket keres a vizsgálat
- Glioma Cohort
- Adult (> 18 years old) patients with newly diagnosed or recurrent high grade glioma with newly confirmed pathology (within 1 month)
- Able to provide informed consent
- No contraindications to MRI with gadolinium contrast or 18F-FAZA PET
- Cervical Cohort
- Adult (>18 years old) female with newly diagnosed cervical cancer
- Able to provide informed consent
- Receiving surgery, radiotherapy or chemotherapy
- No contraindication to MRI with gadolinium contrast or 18F-FAZA PET
Életkor a regiszterben: 18 év – - · 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 |
|---|---|---|---|
| M D Anderson Cancer Center | Houston | Egyesült Államok | Ismeretlen állapot |
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