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Applying PET/MR in Oncology - a Prospective Project

Primary Purpose

Lymphoma, Nasopharyngeal Cancer, Esophageal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PET/MR scan
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lymphoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. patients diagnosed in One of the cancers being investigated.
  2. Only in Sarcoma:20 children and adults with newly diagnosed sarcomas. Children will be included if can perform the study without sedation, and with written parental approval.

Exclusion Criteria:

  1. Patients younger than 18 years.
  2. Pregnancy/
  3. Patients contraindication to MRI or to intravenous gadolinium injection.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Different types of cancer Patients

    Arm Description

    Lymphoma,Nasopharyngeal Cancer; Esophageal Cancer, Cervical cancer; Hepatobiliary and pancreatic cancer; Sarcoma; Prostate Cancer

    Outcomes

    Primary Outcome Measures

    Patients who preformed PET/MR and PET/CT in clinical staging and monitoring of different cancer types will be measured and reported number of Participants in staging and different between their scans/

    Secondary Outcome Measures

    Full Information

    First Posted
    October 29, 2019
    Last Updated
    November 7, 2019
    Sponsor
    Tel-Aviv Sourasky Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04158414
    Brief Title
    Applying PET/MR in Oncology - a Prospective Project
    Official Title
    Applying PET/MR in Oncology - a Prospective Project
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 28, 2019 (Anticipated)
    Primary Completion Date
    January 28, 2020 (Anticipated)
    Study Completion Date
    November 28, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tel-Aviv Sourasky Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Cancer is a global health issue. According to the World Health Organization, Cancer is the second leading cause of death globally, and is responsible for an estimated 9.6 million deaths in 2018. In Israel, more than 30,000 new cases of cancer were diagnosed, and more than 11,000 deaths were cancer-related during 2016. Imaging plays a pivotal role in cancer management, and multiple techniques are used in all phases of cancer management. The overall morphological, structural, metabolic and functional information obtained in imaging is used for improved individualized therapy planning. Different imaging modalities are available during different time points in the natural history of different malignancies: Early detection of cancer through screening based on imaging is probably a major contributor to a reduction in mortality for certain cancers . Once a diagnosis is made, determining the clinical stage of cancer, meaning the extent of the disease before any treatment is given, is a critical element in determining appropriate treatment based on the experience and outcomes of groups of previous patients with similar stage . Precise clinical staging of cancer is crucial. Not only that this clear non-ambiguous description is a key factor that defines prognosis, it is also a chief component of inclusion, exclusion, and stratification criteria for clinical trials. Several cancer staging systems are used worldwide. The most clinically useful staging system is the tumor, node, and metastasis (TNM) staging system developed by the American Joint Committee on Cancer (AJCC) in collaboration with the Union for International Cancer Control (UICC). The AJCC TNM system classifies cancers by the size and extent of the primary tumor (T), involvement of regional lymph nodes (N), and the presence or absence of distant metastases (M). There is a TNM staging algorithm for cancers of virtually every anatomic site and histology, with the primary exception of pediatric cancers. The clinical TNM (cTNM) classification should be used to determine correctly the clinical stage of cancer and to help guide primary therapy planning.
    Detailed Description
    Stage may be defined at several time points during the monitoring period of cancer patients. When using imaging obtained during the relevant time frame, one may use one of the other TNM categories to stage correctly the cancer: For example, imaging is of high value in assessing therapy response during and after systemic and/or radiation therapy is given . Using imaging data and the clinical posttherapy TNM classification (ycTNM) is helpful in determining the patient's response to treatment. In case a patient is given the systemic therapy as a neoadjuvant therapy before a planned curative surgery, imaging may categorize the patient as a responder vs non-responder. If categorized as an early non-responder, another therapy or an upfront surgery may be advised, while eliminating therapy toxicity. If imaging, however, supports major response to treatment, more conservative treatment and avoidance of surgical intervention may be considered and change patients quality of life dramatically. In patients given a systemic therapy as a curative or a palliative therapy, assessing the response via imaging is crucial as well - if imaging studies support a progressive disease, changing therapy protocol is advised. In a disease controlled by the therapy, imaging may aid in guiding follow-up schedule, lifestyle and medical management. In the context of therapy response assessment, imaging is also important in assessing side effects of the therapy. Imaging may identify radiation-induced injuries, and may recognize pathologies associated with chemotherapy, biologic and immunotherapy. Imaging is also critical when recurrence of malignant disease is suspected. In such cases, when signs or symptoms suggest local recurrence, or when raised level of a tumor marker is documented, different imaging techniques can dramatically guide restaging of the disease using the recurrence-TNM classification (rTNM). In such cases imaging may localize the recurrent disease and may guide surgical/radiation/systemic therapy . Different imaging modalities allow assessment of virtually every cancer site and in every time frame during the continuum of the disease. Imaging aids in assessing tumor's size, location, and relationship to normal anatomic structures, as well as the existence of nodal and/or distant metastatic disease. Among the most commonly used imaging modalities are computed tomography (CT), magnetic resonance (MR) imaging, positron emission tomography (PET) and ultrasound. In addition to providing key information for assigning the T, N, and M categories, imaging is invaluable for guiding biopsies and surgical resections. PET imaging has revolutionized the imaging evaluation of cancer . By exploiting biochemical and physiologic differences between tumor cells and normal tissues , PET imaging has become

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lymphoma, Nasopharyngeal Cancer, Esophageal Cancer, Cervical Cancer, Hepatobiliary Cancer, Pancreatic Cancer, Sarcoma, Prostate Cancer

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Different types of cancer Patients
    Arm Type
    Experimental
    Arm Description
    Lymphoma,Nasopharyngeal Cancer; Esophageal Cancer, Cervical cancer; Hepatobiliary and pancreatic cancer; Sarcoma; Prostate Cancer
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    PET/MR scan
    Intervention Description
    500 cancer patients referred to PET-CT assessment will undergo PET/MR scan as well, and the net data will be compared. The overall data will be investigated in groups and subgroups of patients that share similar clinical characteristics and represent cancer patients in different time points during the natural history of their disease. Data analysis will be performed both visually and quantitatively using different MR and PET parameters according to the patient group. Specific populations will be detailed in the next sections per malignancy.
    Primary Outcome Measure Information:
    Title
    Patients who preformed PET/MR and PET/CT in clinical staging and monitoring of different cancer types will be measured and reported number of Participants in staging and different between their scans/
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    120 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients diagnosed in One of the cancers being investigated. Only in Sarcoma:20 children and adults with newly diagnosed sarcomas. Children will be included if can perform the study without sedation, and with written parental approval. Exclusion Criteria: Patients younger than 18 years. Pregnancy/ Patients contraindication to MRI or to intravenous gadolinium injection.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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