Vevsanalyse etter termisk ablasjon for tykktarmskreft Levermetastaser som fører til umiddelbar gjenbehandling
Klinisk utprøving Optimalisering av termisk ablasjon for tykktarmskreft Levermetastaser: Rask vevsanalyse som tillater umiddelbar gjenbehandling; Metabolic Imaging Biomarker Validering; og prediktive 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 2
- Fase 3
Kontakter og plasseringer
Studiekontakt
- Navn: Constantinos Sofocleous, MD, PhD
- Telefonnummer: 212-639-3379
- E-post: sofoclec@mskcc.org
Studer Kontakt Backup
- Navn: Efsevia Vakiani, MD,PhD
- Telefonnummer: 646-888-3060
Studiesteder
-
-
New York
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New York, New York, Forente stater, 10065
- Rekruttering
- Memorial Sloan Kettering Cancer Center
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Ta kontakt med:
- Efsevia Vakiani, MD,PhD
- Telefonnummer: 646-888-3060
-
Ta kontakt med:
- Constantinos Sofocleous, MD, PhD
- Telefonnummer: 212-639-3379
-
Hovedetterforsker:
- Constantinos Sofocleous, MD,PhD
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
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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
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Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Tumor response
Tidsramme: 2 years
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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
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Constantinos Sofocleous, MD, PhD, Memorial Sloan Kettering Cancer Center
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Diagnostiske teknikker og prosedyrer
- Diagnose
- Tomografi
- Diagnostisk avbildning
- Radiografi
- Bildetolkning, datamaskinassistert
- Radiografisk bildeforbedring
- Bildeforbedring
- Fotografi
- Tomografi, røntgen
- Tomografi, emisjon-beregnet
- Radionuklidavbildning
- Diagnostiske teknikker, radioisotop
- Positron-emisjonstomografi
- Tomografi, røntgenberegnet
- Multimodal avbildning
- Positron emission tomography computertomography
Andre studie-ID-numre
- 19-332
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
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