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FDG-PET-CT and Biomarkers in Esophageal Cancer

26. oktober 2016 opdateret af: M.D. Anderson Cancer Center

FDG-PET-CT and Biomarkers to Assess Pathologic Response in Surgical Specimens of Patients With Localized Esophageal Cancer After Chemoradiation

The goal of this clinical research study is to learn if the results of a positron emission tomography/computed tomography (PET/CT) scan done 10-14 days after beginning chemotherapy and radiation (chemoradiation) can predict how a patient with cancer of the esophagus will respond to chemoradiation. Researchers also want to learn if biomarkers (substances in the body associated with cancer) found in tumor tissue can predict response to chemoradiation.

Studieoversigt

Detaljeret beskrivelse

You have cancer of the esophagus and you and your doctor have agreed that you will have treatment with chemoradiation to try to shrink the cancer. You will then have surgery to remove any remaining tumor.

How well cancer of the esophagus responds to chemoradiation varies from person to person. Currently, doctors cannot tell before surgery in which patients the chemoradiation will kill all of the cancer, some of the cancer, or not much of the cancer. Studying patients' PET/CT scans and tumor tissue for biomarkers may help researchers predict how an individual patient will respond to chemoradiation. This could spare future patients from having unnecessary surgery or chemoradiation treatment that is not effective.

PET and CT scans are both standard imaging tests that doctors use to find cancer in the body. The PET scan detects the signal of actively growing cancer cells in the body and the CT scan shows the location, size, and shape of the cancer. Combining these scans provides more complete information on cancer location, growth, and changes in the cancer over time.

Currently, routine testing for esophageal cancer at MD Anderson includes a PET/CT scan at the time of diagnosis and 5 or 6 weeks after chemoradiation is completed. Researchers hope that analyzing changes seen in an "early" PET/CT scan (performed between 10-14 days after starting chemoradiation) compared to the PET/CT scan taken at the time of diagnosis may predict how well the chemoradiation will work against the patient's cancer.

PET/CT Scan:

If you are found to be eligible to take part in this study, 10-14 days after you start your chemoradiation treatment you will have a PET/CT scan performed.

You will need to fast (not have anything to eat or drink except water) for 4-6 hours before the PET/CT scan. Blood (about 1 teaspoon) will be drawn to check your blood sugar level.

You will receive a small amount of fluorodeoxyglucose (FDG) solution by vein. Cancer cells use sugar at a higher rate than normal cells do. FDG is a radioactive form of glucose (sugar) commonly used during a PET scan. The FDG helps show areas in the body where there is cancer cell growth. After receiving the FDG solution, you will rest in a quiet, darkened room for 45-60 minutes before the PET/CT scan. The entire procedure should take about 3 hours.

This PET/CT scan will be compared to your routine PET/CT scan. Your doctor will tell you of the results of this PET/CT scan. However, the results will not change the planned treatment you receive, unless the scan shows that the disease has gotten worse.

Biomarkers Testing:

Researchers will collect samples of tumor tissue previously collected at MD Anderson. This tissue will be used for biomarker testing.

Length of Study:

You will be off active study once you complete the PET/CT scan.

Medical Record Information Collection and Long-Term Follow-Up:

The study staff will collect information from your medical record on tests, evaluations, and treatments you receive as part of your routine care. The study staff will continue to collect this information from your medical record as long as you are a patient at MD Anderson.

If you stop coming to MD Anderson, you will be called by the study staff every 3 months after surgery for the first year and then every 6 months after that. During this call, you will be asked about your health status. The call should take about 5 minutes.

This is an investigational study. PET/CT scans are routine tests for patients with cancer of the esophagus. The early PET/CT scan for the purpose of this study is investigational.

Up to 95 patients will take part in this study. All will be enrolled at MD Anderson.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

31

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • University of Texas MD Anderson Cancer Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Patient must have histologic documentation of adenocarcinoma or squamous carcinoma of the esophagus at M. D. Anderson Cancer Center (MDACC).
  2. Patients with localized carcinoma of the esophagus who have undergone standard testing and been evaluated by the multidisciplinary team at MDACC and are considered appropriate candidates for and are willing to undergo chemoradiation therapy followed by surgery at MDACC. Radiation may be delivered as proton or photon. These patients have clinical stage II or III cancers and they are considered medically fit to undergo surgery.
  3. Patient must have undergone a baseline esophagealgastroduodenoscopy (EGD) with biopsy and endoscopic ultrasonography at MDACC, with tissue available for biomarker analysis.
  4. Patient must have undergone a baseline FDG-PET/CT at MDACC or an outside institution.
  5. Patient must be willing to undergo a research "early" FDG-PET/CT (12 +/- 2 days from the start of chemoradiation).
  6. Patient must provide written informed consent.
  7. Patient must be >/= 18 years of age.

Exclusion Criteria:

  1. Patient is unable or unwilling to comply with the requirements of the protocol.
  2. Patient had baseline FDG-PET/CT scan maximum SUV of < 4.0.
  3. Patient is not a candidate for chemoradiation followed by surgery.
  4. Patients who received induction chemotherapy prior to chemoradiation therapy are excluded.
  5. Patients with T1N0 or T4anyN are excluded.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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: PET/CT Scan + Biomarkers Testing

PET/CT scan with fluorodeoxyglucose (FDG) solution by vein, scan done 10-14 days after beginning chemotherapy and radiation (chemoradiation).

Tissue obtained at MDACC during previous biopsy and at time of post chemoradiation surgery will be used for biomarker analysis.

PET/CT scan with fluorodeoxyglucose (FDG) solution by vein, scan done 10-14 days after beginning chemotherapy and radiation (chemoradiation).
Andre navne:
  • Positron emission tomography/computed tomography
Tissue obtained at MDACC during previous biopsy and at time of post chemoradiation surgery will be used for biomarker analysis.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pathologic Response
Tidsramme: PET-CT at 12 + 2 days after the start of chemoradiation
From baseline PET-CT to "early" PET-CT [12 + 2 days after the start of chemoradiation] Frequency and percentage of pathologic complete response (pathCR) and extreme chemoradiation resistance (exCRTR) patients tabulated. Exploratory graphics, such as box plots, used to illustrate distribution of PET/CT maximum SUV by pathCR (or exCRTR) status. A logistic regression model fit for pathCR (and separately, for exCRTR), with baseline and the change of maximum SUV between baseline and early chemoradiation included as covariates.
PET-CT at 12 + 2 days after the start of chemoradiation

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Jaffer Ajani, M.D. Anderson Cancer Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2009

Primær færdiggørelse (Faktiske)

1. december 2015

Studieafslutning (Faktiske)

1. december 2015

Datoer for studieregistrering

Først indsendt

29. januar 2009

Først indsendt, der opfyldte QC-kriterier

29. januar 2009

Først opslået (Skøn)

2. februar 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

28. oktober 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. oktober 2016

Sidst verificeret

1. oktober 2016

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Spiserørskræft

Kliniske forsøg med PET/CT (FDG PET/CT)

Abonner