Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT04508088

Conditions

Inflammatory Bowel Disease

Crohn Disease

Eligibility Criteria

Sex: All

Age: 13 - 20

Healthy Volunteers: Accepted

Interventions

Coronal T1 weighted spin echo images

Spin-lattice relaxation (T1)

Magnetic resonance spectroscopy

Blood Draw

Study Details

Brief summary:

The investigators will be evaluating bone marrow composition via magnetic resonance imaging in newly diagnosed adolescents with Crohn disease (CD) compared to healthy, matched controls. The investigators will also be assessing their bone mineral density via other imaging modalities, including dual-energy X-ray absorptiometry and peripheral quantitative computed tomography. This longitudinal project will focus on abnormalities in bone marrow composition, and specifically whether adolescents with newly diagnosed CD exhibit increased bone marrow fat, its association with bone mineral density (BMD) and the underlying pathophysiology, including bone turnover markers and immune cellular/molecular parameters.

Conditions

Inflammatory Bowel Disease

Crohn Disease

Study ID

NCT04508088

Start date

Sep 10, 2020

Status verified date

Oct, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 20

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Crohn's Disease diagnosed within the past 3 months, or a healthy, matched control

Exclusion Criteria:

  • Participants with chronic disease known to affect skeletal metabolism
  • Participants on certain medications within the prior 3 months that are known to affect skeletal metabolism
  • Participants who are pregnant
  • Participants who have a history of: claustrophobia, internal body metal that is not compatible with MRI machine, or a known abnormality on or adjacent to the left knee

Study Design

Enrollment

92 participants

Anticipated

Interventions and Outcome Measures

Arms

Crohn Disease

This group will be 46 adolescents, ages 13-20, who have been recently (within 3 months) diagnosed with Crohn Disease.

All participants will have a two study visits approximately one year apart during which the listed diagnostic testing will be performed.

Control

Controls will be matched for age, Tanner staging, and BMI percentile.

All participants will have a two study visits approximately one year apart during which the listed diagnostic testing will be performed.

Interventions

Coronal T1 weighted spin echo images

Coronal T1 weighted spin echo images will be obtained through the knee with a field of view of 16cm to include distal femoral and proximal tibial metaphyses.

Spin-lattice relaxation (T1)

Spin-lattice relaxation (T1) relaxometry acquisition consisting of seven fast spin echo (FSE) acquisitions through the knee. T1 maps from the T1 relaxometry images will be generated using a two-parameter-fit iterative algorithm developed in-house using IDL software (Harris Geospatial Solutions, Melbourne, FL, USA). Mean T1 values for each region will be recorded. The anatomical locations of these regions will be consistent in size for all subjects and location. The locations chosen for the primary endpoints are ones that are known to be rich in red and yellow marrow, respectively.

Magnetic resonance spectroscopy

Magnetic resonance spectroscopy. MRS will be performed within a 1 mL voxel situated in the medial aspect of the distal femoral metaphysis. A single voxel point resolved spectral acquisition (PRESS) technique will be used to acquire non-water suppressed spectra at echo times of 20, 30, 40, and 50 ms using 32 signal averages per echo time with a TR of 2.5 s (total scan time = 5.4 minutes). Spectral fits using JMRUI MRS processing software (www.jmrui.eu) to the water and methylene/methyl resonances will be used to quantify peak areas and establish T2 corrected fat/(fat + water) ratios.

Blood Draw

Blood draw. Blood draws will be used to attain and assess markers of bone formation/resorption and to perform immune studies. Specific markers of bone formation that will be assessed include osteocalcin (OC) and procollagen type 1 N-terminal propeptide (P1NP), and a marker of bone resorption, c-telopeptide (CTX). We will also evaluate molecular gene signatures from the blood samples that correlate with the previously described bone imaging phenotypes. At that point, the information will be used to develop a CyTOF panel to evaluate differences in immune cellular populations between CD patients with normal versus low BMD, and matched controls.

Primary outcome measure

  • Bone marrow adiposity by magnetic resonance imaging (MRI) [ Time Frame: Baseline and One Year follow-up ]
  • Magnetic resonance spectroscopy (MRS) [ Time Frame: Baseline and One Year follow-up ]

Central Contacts and Locations

Central contacts

Rebecca Gordon, MD

(617) 355-7476rebecca.gordon@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Oct 30, 2025

Last verified

Oct, 2025

Keywords

  • Crohn
  • Bone Marrow
  • Dual-energy X-ray absorptiometry
  • Peripheral Quantitative Computed Tomography
  • Magnetic Resonance Imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-10-30.