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Protocol Optimization in CT for the Quantification of BMD

H

Hatem Alkadhi

Status

Completed

Conditions

Osteoporosis, Osteopenia
Bone Loss

Treatments

Diagnostic Test: Bone Mineral Density quantification

Study type

Interventional

Funder types

Other

Identifiers

NCT06305156
CT_BMD_1

Details and patient eligibility

About

Bone mineral density is an important measurement to detect osteoporosis.

The goal of this clinical trial is to compare bone mineral density measurements in CT examinations and DXA scans. The main question it aims to answer is:

  • How good is the measurement of bone mineral density in the new photon-counting CT in comparison to DXA
  • How can we optimize the CT scan for bone mineral density

Participants will undergo:

  • Clinically indicated CT scan on day of inclusion
  • Study related DXA scan on a separate appointment

Enrollment

167 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Informed Consent signed by the subject
  • Referral to a regular clinically indicated CT examination covering the lumbar area (e.g., Abdomen, Thorax + Abdomen, Neck + Thorax +Abdomen)
  • Informed written and oral consent (interpreter present in case of foreign language patients)
  • No contraindication to the clinically indicated CT examination

Exclusion criteria

  • Patients < 18 years
  • Pregnant women
  • Vulnerable subjects
  • Contraindications to the clinically indicated CT scan
  • Multiple Myeloma
  • Diffuse bone metastasis
  • Fixateur interne in the lumbar spine
  • Kyphoplasty in the lumbar spine
  • Enterally administrated contrast agent
  • Obtaining informed consent is not possible
  • Withdrawal of consent orally or in writing
  • Inability to follow the procedures of the investigation, e.g., due to language problems, psychological disorders, dementia, etc. of the subject
  • Immobility (patients confined to a wheelchair or to bed)

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

167 participants in 1 patient group

Bone mineral density CT vs DXA
Other group
Description:
Single arm study, all participants receive CT and DXA.
Treatment:
Diagnostic Test: Bone Mineral Density quantification

Trial contacts and locations

1

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Central trial contact

Hatem Alkadhi, MD, MPH

Data sourced from clinicaltrials.gov

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