Applying PET/MR in Oncology - a Prospective Project

NCT04158414 | Unknown

• 1 other identifier: TASMC-19-ES-0568-CTIL
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lymphoma; Nasopharyngeal Cancer; Esophageal Cancer; Cervical Cancer; Hepatobiliary Cancer; Pancreatic Cancer; Sarcoma; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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/

  1 year

Study Arms (1)

Different types of cancer Patients

EXPERIMENTAL

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

Diagnostic Test: PET/MR scan

Interventions

PET/MR scan DIAGNOSTIC_TEST

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.

Different types of cancer Patients

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients younger than 18 years.
• Pregnancy/
• Patients contraindication to MRI or to intravenous gadolinium injection.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

MeSH Terms

Conditions

Lymphoma; Nasopharyngeal Neoplasms; Esophageal Neoplasms; Uterine Cervical Neoplasms; Pancreatic Neoplasms; Sarcoma; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Neoplasms, Connective and Soft Tissue; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: November 8, 2019
• Study Start: November 28, 2019
• Primary Completion: January 28, 2020
• Study Completion: November 28, 2021
• Last Updated: November 8, 2019

Record last verified: 2019-11