- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01292772
The Effects of Radiation in Reconstructed Breasts
7 april 2020 uppdaterad av: Abramson Cancer Center of the University of Pennsylvania
The Effects of Radiation Therapy on the Reconstructed Breast: An Evaluation Using MR Imaging
The primary objective of this study is to use LR imaging to evaluate the effects of adjuvant radiation therapy on reconstructed breasts.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Immediate breast reconstruction following mastectomy has become an increasingly popular and accepted treatment option among breast cancer patients.
This change in practice has resulted in a significant number of patients who undergo radiation therapy after breast reconstruction.
Following irradiation, the reconstructed breast often experiences fibrotic contracture, volume loss, altered pigmentation, or some combination thereof, producing an asymmetric and aesthetically compromised result.
The effects of radiation on reconstructed breasts as well as the implications that such changes have for timing of reconstructive surgery, post-operative management and surveillance imaging are topics of growing importance in plastic surgery, radiology and surgical oncology.
Studietyp
Observationell
Inskrivning (Faktisk)
12
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Förenta staterna, 19104
- Abramson Cancer Center of the University of Pennsylvania
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 90 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Testmetod
Sannolikhetsprov
Studera befolkning
The target population will consist of patients with a diagnosis of unilateral breast cancer who elect to undero bilateral mastectomy with immediate free flap reconstruction.
Patients will be treated by members of the Division of Plastic and Reconstructive Surgery and will receive postoperative radiation therapy to the affected breast.
Beskrivning
Inclusion Criteria:
- Female patients between 18 and 90 years of age.
- Patients with a diagnosis of unilateral breast cancer who elect to undergo bilateral mastectomy with immediate free flap reconstruction.
- Patients must also have a locally advanced tumor that requires adjuvant radiation therapy following reconstruction.
Exclusion Criteria:
- Women who do not undergo immediate, bilateral breast reconstruction using a free flap.
- Women who do not require unilateral, adjuvant radiation therapy
- Women who are pregnant
- Women who have altered renal function, defined as a personal history of diabetic, hypertensive or autoimmune nephropathy and/or on routine preoperative testing are found to have a serum creatinine greater than or equal to 1.3
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Reconstructed Breast Volume
Tidsram: up to 1 year after radiation
|
This will be compared at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.
|
up to 1 year after radiation
|
Vascular Fibrosis
Tidsram: up to 1 year after radiation
|
This will be compared at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.
|
up to 1 year after radiation
|
Dermal Thickness
Tidsram: up to 1 year after radiation
|
This will be compared at 2 pionts: before radiation and 1 year after radiation is completed between the 2 breasts
|
up to 1 year after radiation
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Presence of Fat Necrosis in the Breast
Tidsram: up to 1 year after radiation
|
This will be assessed at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.
|
up to 1 year after radiation
|
Evidence of Cancer Recurrence
Tidsram: up to 1 year after radiation
|
This will assessed at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.
|
up to 1 year after radiation
|
Symmetry
Tidsram: up to 1 year after radiation
|
This will be assessed at 2 points; before radiation and 1 year after radiation is completed between the 2 breasts.
|
up to 1 year after radiation
|
Hyperpigmentation
Tidsram: up to 1 year after radiation
|
This will be assessed at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.
|
up to 1 year after radiation
|
Contracture
Tidsram: up to 1 year after radiation
|
This will be assessed at 2 points:before radiation and 1 year after radiation is completed between the 2 breasts.
|
up to 1 year after radiation
|
Aesthetic Result
Tidsram: up to 1 year after radiation
|
This will be assessed at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.
|
up to 1 year after radiation
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 december 2010
Primärt slutförande (Faktisk)
1 december 2016
Avslutad studie (Faktisk)
5 maj 2019
Studieregistreringsdatum
Först inskickad
1 februari 2011
Först inskickad som uppfyllde QC-kriterierna
9 februari 2011
Första postat (Uppskatta)
10 februari 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
8 april 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
7 april 2020
Senast verifierad
1 april 2020
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- UPCC 12110
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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