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Fludeoxyglucose F 18 PET/CT Imaging in Finding Cancer in Patients Undergoing Surgery for Solid Tumors

31 marca 2016 zaktualizowane przez: Stephen Povoski, Ohio State University Comprehensive Cancer Center

Pilot Study Evaluating a Combined and Integrated Technological Approach of F-18-FDG-Directed Perioperative PET/CT Imaging and Intraoperative Handheld Gamma Prove Detection of Known and Occult Disease in Patients Undergoing Surgery for Solid Malignancies

The purpose of this pilot study is to evaluate a combined and integrated technological approach of 18F-FDG-directed perioperative PET/CT imaging and intraoperative handheld gamma probe detection of known and occult disease in patients undergoing surgery for solid malignancies.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

OBJECTIVES:

  1. To determine if the perioperative PET/CT imaging (consisting of preoperative PET/CT imaging, specimen PET/CT imaging, and postoperative PET/CT imaging) combined with intraoperative use of the handheld gamma probe is feasible during a surgical procedure to resect malignancy.
  2. To evaluate if perioperative PET/CT imaging can assist in intraoperatively localizing tumor and verify complete resection of disease.
  3. To evaluate intraoperative detection of tumor sites using a handheld gamma probe after preoperative injection of 18F-FDG combined with preoperative PET/CT imaging.
  4. To evaluate specimen PET/CT imaging using the preoperative 18F-FDG dose for detecting presence of tumor within the specimen and for assessing surgical margins.
  5. To evaluate specimen MRI imaging for detecting presence of tumor within remnant tissue of appropriately selected resected specimens and for assessing surgical margins.
  6. To evaluate standard pathology sampling with image guided pathology sampling (using specimen PET/CT imaging) in order to determine if sensitivity and accuracy of pathologic evaluation may be improved with PET/CT image guidance.
  7. To compare activity of surgical specimen samples in a well counter and correlate activity with pathologic findings and tumor burden in order to determine if the concepts in the previous two specific aims can be utilized to benefit patients treated at centers without access to PET/CT imaging equipment.

OUTLINE: Patients undergo pre- and postoperative fludeoxyglucose F 18 (^18FDG) PET/CT imaging. An intraoperative handheld gamma probe is used to detect ^18FDG-avid tissues. Resected specimens are assessed by ^18FDG PET imaging for intraoperative verification of complete tumor resection.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

65

Faza

  • Wczesna faza 1

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Ohio
      • Columbus, Ohio, Stany Zjednoczone, 43210-1240
        • Ohio State University Medical Center

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Patients must be 18 years of age or older.
  • Patients must either have a histologic-confirmed solid malignancy or have a suspected solid malignancy which has required a diagnostic preoperative PET/CT scan or for which a diagnostic preoperative PET/CT scan has been recommended
  • Patients must clinically have been determined to be a candidate for the indicated surgical procedure.
  • Patients may have had prior surgery and/or chemotherapy with no limit to the number of prior therapeutic procedures or chemotherapeutic regimens.
  • Patients must have a performance status of 0, 1 or 2 by ECOG standards.
  • Patients must give written informed consent, including consent to have IV line placed for 18F-FDG administration.
  • Females of childbearing age must have a negative pregnancy test (by Beta HCG qualitative analysis), must have had a history of a surgical sterilization, or must give history of no menses in past twelve months.
  • Fasting blood sugar less than 200 mg/dl.

Exclusion Criteria:

  • Any patient with active CNS tumor involvement.
  • Any patient who is pregnant or lactating.
  • Any patient with a body size and habitus that is determined to prohibit use of the diagnostic equipment.
  • Any patient with a tumor burden that is determined to be so great (as determined by preoperative PET/CT scanning or intraoperative findings) that further surgery is not advised.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Diagnostyczny
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Arm 1
F-FDG-directed surgery for known or suspected malignancy using gamma detection probes.
Procedura: PET/CT scan
For all patients undergoing a preoperative PET/CT scan on the day of surgery, at approximately 70 minutes post-injection of 18F-FDG, a diagnostic whole body PET/CT scan will be obtained on a Siemens Biograph 16 PET/CT scanner (Siemens, Knoxville, TN).
Inne nazwy:
  • Pozytonowa emisyjna tomografia komputerowa
  • Tomografii komputerowej
Lek: 18F-FDG Injection
Patients undergoing a preoperative PET/CT scan the day of surgery, are required to have fasted for at least 4 hours prior to the anticipated preoperative PET/CT scan. Patients participating in this pilot study (whether they have had their preoperative PET/CT scan prior to the day of surgery or whether they are having their preoperative PET/CT scan on the day of surgery) will receive a preoperative IV injection into a peripheral vein of 15 mCi of 18FFDG at time interval of approximately 60 to 180 minutes prior to anticipated time of surgery.
Inne nazwy:
  • Fludeoxyglucose
  • fdg
Procedura: Preoperative 18F-FDG PET/CT Scan
Patients undergoing preoperative PET/CT scan day of surgery, at approximately 70 minutes post-injection of 18F-FDG, a diagnostic whole body PET/CT scan will be obtained. PET imaging will immediately be preceded by noncontrast transmission CT (for attenuation correction and anatomic correlation purposes) and will be obtained from the base of the skull to the mid thighs. Bed positions will be scanned for 3 minutes each, moving the patient through the scanner in a craniocaudal direction. Once the preoperative PET/CT scan is acquired, images will be reviewed by the nuclear medicine physician and the surgeon.
Inne nazwy:
  • Pozytonowa emisyjna tomografia komputerowa
  • Tomografii komputerowej
  • Fludeoxyglucose
  • fdg
Lek: 18F-FDG for patients with Bladder Cancer
Elimination of 18F-FDG by the urinary system and accumulation in the bladder impacts the differentiation between residual 18F-FDG in the bladder and activity in tumor and adjacent lymph nodes. For patients with bladder cancer, the urinary catheter routinely placed in the operating room will be inserted in the Ambulatory Surgery Unit (ASU) by the urologist on-service or the urology research nurse. A 3-way Foley catheter will be placed for continuous bladder irrigation with Normal Saline (0.9%) initiated in ASU and will continue for the duration of the imaging procedure at a standard rate of 10cc/minute. The urology research nurse will transport the patient to and from the PET/CT area and monitor the continuous bladder irrigation during the imaging session.
Inne nazwy:
  • Fludeoxyglucose
  • fdg
Procedura: Surgical Procedure
Previously determined operative procedure based on type of solid malignancy. Factors include extent and location of disease, physiologic status of patient intraoperatively, any technical considerations influenced by anatomic constraints, and a risk: benefit analysis of proposed procedure. The decision to proceed with resection on these factors, and will constantly re-evaluate during resection to ensure patient well-being, both short and long term, is foremost consideration. Evaluation of extent of disease during surgical exploration will include inspection and palpation of entire area being evaluated. Tissue that is highly suspicious for involvement with metastatic disease that alters the surgical decision making plan of resection will be biopsied or resected for histologic confirmation if feasible and safe. If patient is found to have resectable disease, deemed safe patient, surgeon will continue and proceed with definitive surgical resection with assistance of handheld gamma probe.
Procedura: Specimen PET/CT Scan
Resected surgical specimen will be placed on top of paraffin block. Digital photos of the specimen will be obtained for visual correlation of specimen placement on paraffin block. Two bed position 10 minute specimen PET/CT scan will be performed on surgical specimen. If remnant tissue is available, a second image maybe acquired via MRI. Images will be processed and reviewed for quality and presence or absence of hypermetabolic foci and correlated with anatomical information provided by CT and MRI imaging that were originally noted in the preoperative clinical PET/CT scan. During the time when the excised surgical specimens are transported to radiology for specimen PET/CT scanning, additional evaluation of these ex-vivo specimens with other tumor detection devices may be undertaken. Specimen will then be transported back to the operating room in order to be sent to and processed by surgical pathology for standard pathologic evaluation.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Ramy czasowe
Determine perioperative PET/CT imaging combined with intraoperative use of handheld gamma probe is feasible during surgical procedure to resect malignancy.
Ramy czasowe: up to five years
up to five years

Miary wyników drugorzędnych

Miara wyniku
Ramy czasowe
Evaluate if perioperative PET/CT imaging can assist in intraoperatively localizing tumor and verify resection of disease.
Ramy czasowe: up to five years
up to five years
Evaluate intraoperative detection of tumor sites using a handheld gamma probe after preoperative injection of 18F-FDG combined with preoperative PET/CT imaging.
Ramy czasowe: up to five years
up to five years
Evaluate specimen PET/CT imaging using the preoperative 18F-FDG dose for detecting presence of tumor within the specimen and for assessing surgical margins.
Ramy czasowe: up to five years
up to five years
Evaluate specimen MRI imaging for detecting presence of tumor within remnant tissue of appropriately selected resected specimens and for assessing surgical margins.
Ramy czasowe: up to five years
up to five years
Evaluate standard pathology sampling with image guided pathology sampling (using specimen PET/CT imaging) in order to determine if sensitivity and accuracy of pathologic evaluation may be improved with PET/CT image guidance.
Ramy czasowe: up to five years
up to five years
Compare activity of surgical specimen samples with pathologic findings and tumor burden in order to determine if the concepts in previous two specific aims can be utilized to benefit patients treated at centers without access to PET/CT imaging equipment.
Ramy czasowe: up to five years
up to five years

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Ohio State University Comprehensive Cancer Center

Śledczy

  • Główny śledczy: Stephen P. Povoski, MD, Ohio State University Comprehensive Cancer Center

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 października 2008

Zakończenie podstawowe (Rzeczywisty)

1 sierpnia 2011

Ukończenie studiów (Rzeczywisty)

1 sierpnia 2011

Daty rejestracji na studia

Pierwszy przesłany

31 grudnia 2008

Pierwszy przesłany, który spełnia kryteria kontroli jakości

31 grudnia 2008

Pierwszy wysłany (Oszacować)

1 stycznia 2009

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

4 kwietnia 2016

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

31 marca 2016

Ostatnia weryfikacja

1 marca 2016

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • OSU-08031
  • NCI-2012-00958 (Identyfikator rejestru: Clinical Trials Reporting Program (CTRP))

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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