Use of 11C-choline for the evaluation of Multiple Mieloma in staging - COLINA-MM01/2008

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-004851-31-IT

Enrollment

Registered

2008-11-19

Start date

2008-10-21

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

staging of Multiple Mieloma MedDRA version: 9.1 Level: LLT Classification code 10028228 Term: Multiple myeloma

Interventions

Product Name: 11C-Choline Product Code: 11C-C Pharmaceutical Form: Solution for infusion INN or Proposed INN: 11C-Choline Current Sponsor code: 11C-C Concentration unit: MBq megabecquerel(s) Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of Mutiple Myeloma 2. Age > 18 3. Informed consent signed Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Breast feeding 3. Healthy volunteers 4. Age <18 5. Patients in emergency state 6. Individuals with reduced approval competence expressing any reluctance to participate to the study as well as those not understanding the purpose of the study 7. Informed consent not signed

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Comparison of the number of bone lesions detected by 11C-choline PET/CT vs 18F-FDG PET /CT and Whole Body X Ray);Main Objective: This study is aimed to evaluate the sensitivity of 11C-choline PET for the evaluation of bone involvement in patients affected by Multiple Myeloma in staging, in comparison to conventional diagnostic flow-chart (18F-FDG PET /CT, and Whole Body X Ray).;Secondary Objective: NONE	—

Measure

Time frame

Primary end point(s): Comparison of the number of bone lesions detected by 11C-choline PET/CT vs 18F-FDG PET /CT and Whole Body X Ray);Main Objective: This study is aimed to evaluate the sensitivity of 11C-choline PET for the evaluation of bone involvement in patients affected by Multiple Myeloma in staging, in comparison to conventional diagnostic flow-chart (18F-FDG PET /CT, and Whole Body X Ray).;Secondary Objective: NONE

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026