Vævsanalyse efter termisk ablation for tyktarmskræft Levermetastaser, der fører til øjeblikkelig genbehandling
Klinisk forsøg Optimering af termisk ablation for tyktarmskræft Levermetastaser: Hurtig vævsanalyse, der muliggør øjeblikkelig genbehandling; Metabolic Imaging Biomarker Validering; og forudsigelige genetiske signaturer
This study will see whether collecting and analyzing needle biopsy samples from cancer liver metastases after a tumor ablation procedure will be able to identify cancer cells that are still alive. The results of these biopsies could help determine the next treatment for your cancer, but the biopsies could cause side effects.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: Constantinos Sofocleous, MD, PhD
- Telefonnummer: 212-639-3379
- E-mail: sofoclec@mskcc.org
Undersøgelse Kontakt Backup
- Navn: Efsevia Vakiani, MD,PhD
- Telefonnummer: 646-888-3060
Studiesteder
-
-
New York
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New York, New York, Forenede Stater, 10065
- Rekruttering
- Memorial Sloan Kettering Cancer Center
-
Kontakt:
- Efsevia Vakiani, MD,PhD
- Telefonnummer: 646-888-3060
-
Kontakt:
- Constantinos Sofocleous, MD, PhD
- Telefonnummer: 212-639-3379
-
Ledende efterforsker:
- Constantinos Sofocleous, MD,PhD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Diagnosis of liver metastases from various primary tumors
- Confined liver disease or limited extrahepatic disease stable/controlled for at least 4 months (extrahepatic disease amenable to treatment is allowed)
- Lesions of ≤3 cm in maximum diameter
- At least one FDG-avid lesion to be treated***
- INR < 1.5*
- Platelet count ≥ 50,000
Exclusion Criteria:
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Age < 18
-
Less than 5 mm distance to a structure (GI or biliary tract), that cannot be protected from ablation injury with technical modifications such as hydro or air dissection
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INR > 1.5 that cannot be corrected with fresh frozen plasma **
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Platelet count of <50,000 that cannot be corrected with transfusion
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More than 3 tumors in the liver
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More than 5 tumors of extrahepatic disease (including mediastinal nodes and pulmonary nodules, abdominal or other lymph nodes, and bone metastasis)
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Presence of any peritoneal Carcinomatosis
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For patients on Coumadin, general clinical guidelines for IR ablation will be followed.
- For patients with no FDG-PET avid tumors aim 2 of the protocol will not be assessed
-
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Patients with Liver Metastases
The standard of care tumor ablation procedure, post-ablation biopsies and pre- and post-ablation PET scans. If the PET scan is positive (shows areas of cancer in the treated metastases), study participants will undergo additional needle biopsies of the positive areas on the scan. If the biopsies show areas of cancer cells that are still alive, the participants will be immediately retreated with a second ablation procedure. |
Patients will undergo a limited non-contrast CT and first injection PET to localize the lesion Standard ablation with the intent to create a radius of ablation at least 10 mm larger than the largest lesion diameter in order to achieve a minimum of 5 mm ablation margin around the tumor. Any radiographically-identified and biopsy-confirmed residual tumor will be treated on site with immediate ablation. This repeat ablation is not standard of care but will be performed as described for the initial ablation (in the same procedure session) and follow up will be resumed. Eligible patients will undergo PET/CT -guided tumor ablation as per standard IR guidelines. All patients will undergo PET/CT again, within approximately 6 weeks (+/- 2 weeks) of tumor ablation to evaluate for CN in the target tumor(s) or any sign of residual tissue enhancement, representing viable residual tumor and incomplete treatment. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Tumor response
Tidsramme: 2 years
|
will be measured according to RECIST and PERCIST 1.0. The first CT and PET scan taken after ablation will be considered the new baseline for subsequent comparisons and measurements. |
2 years
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Constantinos Sofocleous, MD, PhD, Memorial Sloan Kettering Cancer Center
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Diagnostiske teknikker og procedurer
- Diagnose
- Tomografi
- Diagnostisk billeddannelse
- Radiografi
- Billedtolkning, computerassisteret
- Radiografisk billedforbedring
- Billedforbedring
- Fotografering
- Tomografi, røntgenbillede
- Tomografi, emission-kompettet
- Radionuclide Imaging
- Diagnostiske teknikker, radioisotop
- Positron-emissionstomografi
- Tomografi, røntgenbillede
- Multimodal billeddannelse
- Positronemissionstomografi Computertomografi
Andre undersøgelses-id-numre
- 19-332
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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