- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01666899
Effect of Radiation on Tissue for Delayed Breast Reconstruction
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
- University of Michigan
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
To evaluate cellular and histologic changes in mastectomy skin over time following completion of radiation therapy.
Tidsramme: 2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction
|
2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
To evaluate the vascular density of the skin and perfusion changes following radiation therapy.
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Tidsramme |
---|---|
To evaluate changes in internal mammary vessel structure and flow characteristics over time following completion of radiation therapy.
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Adeyiza Momoh, MD, Univeristy of Michigan
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 (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2012.032
- HUM00059038 (Anden identifikator: University of Michigan Medical School IRB)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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