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Applying PET/MR in Rectal Cancer.

Applying PET/MR in Rectal Cancer.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04154124
Enrollment
20
Registered
2019-11-06
Start date
2019-11-23
Completion date
2021-12-23
Last updated
2019-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Brief summary

The use of the novel recently introduced PET/MR scanner is believed to be promising in RC management, providing great anatomical details and detailed metabolic characterization. Preliminary data indicate it may become a strong imaging modality for staging of RC and has the potential to be used as a predictive tool guiding individualized therapy in patients receiving nT, but confirmation on prospective studies is mandatory. The use of radiomics as analysis approach may assist in achieving a better understanding of the obtained image data, and thus a more accurate disease assessment. Objectives 1. To preliminary assess the potential diagnostic value of single PET/MR scan in RC staging and compare it to that of MRI alone, PET/CT alone, and combined MRI and PET/CT. 2. To preliminary assess the potential value of PET/MR in predicting pMR to nT. 3. To use radiomics analysis of PET/MR data to develop a quantification clinical tools that allow a more accurate and comprehensive assessment of RC patients.

Interventions

DIAGNOSTIC_TESTPET/MR scan

whole-body PET/CT scan and pelvic PET/MR scan (MR protocol will include three plane fast spin echo T2 weighted, DWI and dynamic contrast enhanced imaging). The ad interim assessment will use a pelvic PET/MR scan only (without PET/CT), to avoid the radiation associated with whole body CT. In the staging and post-nT assessment, the addition of PET/MR to the standard use of PET/CT adds no radiation exposure.

Sponsors

Tel-Aviv Sourasky Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

1.Patients with newly diagnosed RC; histopathological confirmation of adenocarcinoma of colorectal origin.

Exclusion criteria

1. Patients younger than 18 years; 2. pregnancy; 3. other known active malignancy; 4. previous chemotherapy or radiotherapy; 5. previous pelvic operation; 6. patient that no intent / not suited for neoadjuvant therapy (including metastatic disease at presentation); contraindication to intravenous contrast agents.

Design outcomes

Primary

MeasureTime frame
Number of patient that shown the different between diagnostic value of single PET/MR scan in RC staging and compare it to that of MRI alone, PET/CT alone, and combined MRI and PET/CT1 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026