- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01307852
In Vivo Dosimetry During Prostate Cancer Radiotherapy
Pilot Study to Evaluate In Vivo Plastic Scintillation Detectors for Real-Time Radiation Dosimetry During Prostate Cancer Radiotherapy
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
As a part of your standard of care, you will have external beam radiation therapy. You will have a computerized tomography (CT) scan of the pelvis before the external beam radiation therapy.
For the CT scan, you will be given an enema to empty your bowel, and you will drink about 16 to 24 ounces of water to fill your bladder
A rectal balloon will then be inserted into your rectum and filled with either air or water. You will then have the CT scan. The CT scan should take about 45 minutes.
If you agree to take part in this study, very thin (millimeter-sized) radiation detectors will be attached to the rectal balloon during each of two CT scans per week you will have while you are receiving radiation. You may have additional CT scans (without the detector) each week if your doctor thinks it is needed.
The doses read by the radiation detectors will be compared to the doses that you were originally scheduled to receive after each radiation treatment and at the end of the study.
You will be off study after your final radiation treatment using the rectal balloon.
This is an investigational study. Up to 15 patients will take part in this study. All will be enrolled at MD Anderson.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
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Texas
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Houston, Texas, Forenede Stater, 77030
- University of Texas MD Anderson Cancer Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Any patients with prostate cancer who are undergoing routine radiation therapy for their prostate cancer, including post-prostatectomy patients.
- The selection criteria will be limited to the patient's ability to withstand insertion of a rectal balloon and his willingness to participate in the study.
- We will choose patients undergoing photon and proton treatments.
Exclusion Criteria:
N/A
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: In Vivo Dosimetry
Modified endorectal device capable of real-time dose measurement during prostate radiation therapy
|
Radiation detectors attached to rectal balloon for each CT scan done during each radiation treatment.
Treatment delivery Monday through Friday for 7 weeks.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Measurement of True In Vivo Radiation to Rectal Wall During Prostate Radiotherapy
Tidsramme: Twice a week for 7 week treatment.
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Twice a week in vivo measurements of radiation dose absorbed by the rectal wall during intensity-modulated radiotherapy (IMRT) of prostate.
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Twice a week for 7 week treatment.
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Sam Beddar, PHD, M.D. Anderson Cancer Center
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2010-0427
- NCI-2011-00863 (Registry Identifier: NCI CTRP)
- 1R01CA120198-01A2 (U.S. NIH-bevilling/kontrakt)
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