Detection of bone marrow metastases by FDG-PET/CT in patients with rhabdomyosarcomas

Detection of bone marrow metastases by FDG-PET/CT in patients with rhabdomyosarcomas - KM Dx bei RMS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00030887

Enrollment

300

Registered

2025-03-10

Start date

2023-03-21

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

rhabdomyosarcoma

Interventions

Group 1: Our retrospective analysis aims to re-evaluate FDG-PET/ CT images at initial diagnosis and reports of findings from bone marrow punctures at initial diagnosis in patients with rhabdomyosarcom

Eligibility

Sex/Gender

All

Age

No minimum to 40 Years

Inclusion criteria

Inclusion criteria: - diagnosis of rhabdomyosarcoma - informed consent to participate in SoTiSar registry - date of diagnosis after 2009 (this timepoint was chosen, because FDG-PET/CT scans performed earlier than that do not provide sufficient information to answer the study questions)

Exclusion criteria

Exclusion criteria: - no diagnosis of rhabdomyosarcoma - lack of informed consent to participate in SoTiSar registry - date of diagnosis in 2009 or earlier

Design outcomes

Primary

Measure	Time frame
1) To confirm >92% sensitivity and specificity of FDG-PET/CT imaging in detecting bone marrow involvement in RMS (using bone marrow biopsies/ aspirates as the gold standard) 2) To show that re-assignment of bone marrow status by FDG-PET/CT does not result in a change in management for patients with PET+/biopsy- or PET-/ biopsy+ bone marrow status.	—

Secondary

Measure	Time frame
1) To confirm FDG avidity of RMS. 2) To explore the patterns of bone marrow involvement by RMS (diffuse vs. (multi-)focal) and potential correlation of FOXO1 fusion status with differences in patterns of bone marrow involvement in RMS. 3) To explore the differences in EFS between patients with (i) PET+/biopsy+, (ii) PET+/biopsy-, (iii) PET-/ biopsy+ and (iv) PET-/biopsy- bone marrow status? 4) To explore the real-world quality of FDG-PET/CT images and direct bone marrow assessment	—

Measure

Time frame

1) To confirm FDG avidity of RMS. 2) To explore the patterns of bone marrow involvement by RMS (diffuse vs. (multi-)focal) and potential correlation of FOXO1 fusion status with differences in patterns of bone marrow involvement in RMS. 3) To explore the differences in EFS between patients with (i) PET+/biopsy+, (ii) PET+/biopsy-, (iii) PET-/ biopsy+ and (iv) PET-/biopsy- bone marrow status? 4) To explore the real-world quality of FDG-PET/CT images and direct bone marrow assessment

—

Countries

France, Germany, Italy, Netherlands, United States

Contacts

Public ContactSimone Hettmer

Universitätsklinikum Freiburg, Kinder- und Jugendklinik, Klinik für Pädiatrische Hämatologie und Onkologie

simone.hettmer@uniklinik-freiburg.de+4976127043000

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026