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Completed

NCT Number: NCT02969564

18F-NaF-PET/MR vs 99mTc-MDP-SPECT/CT to Detect Bone Metastases in Prostate Cancer Patients.

The number of metastases in a patient with primary or recurrent prostate cancer has major prognostic implication.

The purpose is to compare, in a pilot study, the diagnostic performance of 18F-NaF-PET/MR with respect to the results of the scintigraphy 99mTc-MDP-SPECT/CT (routine exam) for determining the presence or absence of bone lesions in prostate cancer patient, with up to five metastases (oligo-bone metastatic) based on scintigraphy 99mTc-MDP-SPECT/CT. The gold standard will be a combination of clinical follow-up, additional imaging and biopsy, as indicated by the multidisciplinary discussion at the tumor board. The findings from whole-body 99mTc-MDP-SPECT/CT, 18F-NaF-PET/MR, and the combination of the 2 modalities will be categorized by 2 teams of 2 readers as benign or probably benign, equivocal, or malignant or probably malignant and compared with the results of follow-up for JAFROC and ROC analysis.

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Key information

Conditions

Bone Metastases Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Geneva University Hospital

Geneva, 1205, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Oligo- metastatic patient with prostate cancer and bone lesions (up to five metastases) based on scintigraphy and whole-body SPECT/CT (staging or recurrence).
  • Patient must be able to provide informed consent.
  • Patient is ≥ 18 years old

Exclusion criteria

  • Patient with another active malignancy.
  • Patient is < 18 years old
  • Patients with contraindications of MRI procedure (metal implants, cardiac pacemakers, old type of prosthesis)
  • Patients with severe renal impairment (MDRD < 30)

Treatment and study plan

scintigraphy 99mTc-MDP-SPECT/CT.

Other

SPECT/CT will be performed for every patient in the frame of their clinical follow up

18F-NaF-PET/MR

Other

a 18F-NaF-PET/MR will be performed, in the frame of this clinical study, to the patients to assess the difference of sensitivity of the 2 exams

Primary outcomes

  1. Compare the diagnostic performance of 18F-NaF-PET/MR scanning to that of whole body 99mTc-MDP-SPECT/CT for detecting cancer that has spread to the bone (bone metastasis)

    Time frame: through study completion, an average of 2 years

    the primary measure will be differences in the area under the curves (AUC) of the receiver operating characteristic (ROC) curves that will be generated from the interpretations of each technology.

Secondary outcomes

  1. To assess differences in sensitivity and specificity in detecting bone metastases between the two imaging modalities.

    Time frame: through study completion, an average of 2 years

    Sensitivity and specificity of PET and SPECT for the detection of secondary bone lesions (gold standard: clinical and imaging follow up)

  2. To determine the number of equivocal and diagnostic tests resulting from the two imaging modalities.

    Time frame: through study completion, an average of 2 years

    rate of equivocal/non equivocal findings for the two modalities

Sponsors and collaborators

Lead sponsor

Valentina Garibotto

Other

Collaborators

  • University Hospital, Geneva

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
Nov 21, 2016
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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