Effect of Radiation on Tissue for Delayed Breast Reconstruction
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
In the setting of post-mastectomy radiation therapy delayed autologous reconstruction, favored by many attempts to avoid complications encountered with radiating the immediately reconstructed breast. The timing of delayed reconstruction is however not known. The goal of this proposal is to study the gross, structural and vascular changes in radiated mastectomy skin in addition to possible structural and flow changes of the underlying internal mammary vessels over time. We plan to use these objective findings as a basis for determining an ideal time frame for delayed autologous breast reconstruction.
Sequential mastectomy skin specimens will be obtained from 20 patients undergoing post-mastectomy radiation therapy over a 24 month period and these specimens will be evaluated histologically. These same patients will also undergo serial examinations and photographic documentation of gross skin changes. Skin perfusion will be assessed by laser Doppler imaging and internal mammary vessel structure, and flow characteristics will be assessed by color Doppler sonography.
Based on these studies, we will elucidate short and long term changes in radiated breast skin, showing inflammatory, structural and perfusion patterns that can be correlated with optimal conditions for reconstruction. This has the potential to dramatically change practice patterns of delayed reconstruction for many reconstructive surgeons and more importantly restore what patients loose with mastectomy in a consistent, timely fashion. There is also potential for improved outcomes of delayed breast reconstruction by decreasing the number of reconstructions performed too soon after completion of radiation.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Michigan
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Ann Arbor, Michigan, Verenigde Staten, 48109
- University of Michigan
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Patients with invasive breast cancer who will require mastectomy and postmastectomy radiation therapy.
- Patients who meet criteria 1, who plan on postmastectomy breast reconstruction
Exclusion Criteria:
- Male patients
- Patients under the age of 18
- Patients of advanced age (greater than 75)
- Patients with comorbidities that affect wound healing.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Skin and blood vessel procedures
All patients will be placed into Arm 1.
They will undergo punch biopsies of the breast skin at the time of mastectomy and at 2, 4, 6, 8 and 12 months after completion of radiation therapy.
Three more biopsies will be taken at 3, 6, and 12 months after completion of reconstruction.
Patients will also undergo skin blood flow studies with a laser imaging device prior to each biopsy procedure.
Ultrasound studies of the chest vessels will be performed 4 times over the course of the study- once prior to radiation and at 2, 6 and 12 months after radiation.
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Biopsies, skin blood flow studies and ultrasound studies will be performed as described.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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To evaluate cellular and histologic changes in mastectomy skin over time following completion of radiation therapy.
Tijdsspanne: 2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction
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2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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To evaluate the vascular density of the skin and perfusion changes following radiation therapy.
Tijdsspanne: 2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction
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2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction
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Andere uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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To evaluate changes in internal mammary vessel structure and flow characteristics over time following completion of radiation therapy.
Tijdsspanne: 2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction
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2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Adeyiza Momoh, MD, Univeristy of Michigan
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 2012.032
- HUM00059038 (Andere identificatie: University of Michigan Medical School IRB)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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