Evaluating Gut Imaging and Stool Biomarkers in Patients With Scleroderma-associated Gastrointestinal Disease

Summary

Systemic sclerosis (SSc) is characterized by autoimmunity and vasculopathy resulting in fibrosis of the skin and internal organs including the Gastrointestinal (GI) tract. Key unmet clinical needs are the availability of non-invasive biomarkers for early diagnosis of SSc-GI, further characterization of different stages of SSc-GI and SSc-GI treatment response. The investigators propose combining MRI FDG-PET with MRI T1-MOLLI mapping, which has been applied to cardiac imaging to quantify histologically correlated cardiac fibrosis. T1-MOLLI enables detection and quantification of diffuse fibrosis without the need for contrast.

Aim 1: FDG-PET-MRI imaging (primary biomarker) and stool markers (secondary biomarker) will be compared between patients with VEDOSS/early SSc and those with late SSc not on immunosuppressive treatment.

Aim 2: Evaluation of change in biomarker levels from pre-treatment baseline to 6 months (primary end-point) and 12-months (secondary end-point) following MMF treatment, in early SSc patients

Using precision medicine approach in diagnosis and treatment evaluation, the investigators anticipate that this study will contribute significantly to advance management strategies for, and improve outcomes of SSc-GI disease.

Conditions

• Systemic Sclerosis
• Scleroderma

Interventions

DIAGNOSTIC_TEST

PET-MRI scan

Participants will be scanned centrally at Clinical Imaging Research Centre (CIRC, Singapore), on a Biograph mMR PET-MR scanner. Combined FDG-PET-MRI scan is critical for co-registration of peristaltic bowel for optimal image quality. The oesophagus to anorectum will be imaged. The PET-MRI scan starts 60 minutes post-FDG injection of 6mCi and immediately after injecting 10mg hyoscine butylbromide to reduce peristalsis. MRI sequences are non-contrast.

Sponsors & Collaborators

• National University Hospital, Singapore

  collaborator OTHER

• Tan Tock Seng Hospital

  collaborator OTHER

• Changi General Hospital

  collaborator OTHER

• Sengkang General Hospital

  collaborator OTHER

• National University of Singapore

  collaborator OTHER

• Nanyang Technological University

  collaborator OTHER

• Duke-NUS Graduate Medical School

  collaborator OTHER

• Singapore General Hospital

  lead OTHER

Principal Investigators

• Andrea Low · Singapore General Hospital

Eligibility

Min Age

21 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-04-09

Primary Completion

2023-01-31

Completion

2023-01-31

Countries

• Singapore

Study Locations