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NCT05527483
Digital PET/CT Using [Ga-68]PSMA vs. [F-18]NaF for Evaluation of Osseous Metastatic Involvement in Prostate Cancer Patients
trial testing [68Ga]PSMA in Prostate Cancer in 32 participants. Completed in 10 October 2022.
10 October 2022
Quick facts
| Lead sponsor | University Hospitals Cleveland Medical Center |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 32 |
| Start date | 21 April 2022 |
| Primary completion | 10 October 2022 |
| Estimated completion | 10 October 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- [68Ga]PSMA
- Flourine-18 [F-18] Sodium Fluoride (NaF) — full drug profile →
- PET/CT
Conditions studied
- Prostate Cancer — all drugs for Prostate Cancer →
Sponsor
University Hospitals Cleveland Medical Center
Who can join
18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate a radioactive diagnostic study drug, which is called Gallium-68 Prostate Specific Membrane Antigen (\[Ga-68\]PSMA) for detection of bone metastasis in patients with prostate cancer. For imaging the investigators will use a FDA approved imaging technology, digital Positron Emission Tomography (PET/CT). The investigators would like to know if digital PET/CT using \[Ga-68\]PSMA provides accurate information about the extent of bone metastases. Therefore, the investigators will compare\[Ga-68\]PSMA PET/CT with Flourine-18 \[F-18\] Sodium Fluoride (NaF), which is a high resolution bone scan. \[F-18\]NaF is FDA approved and the reference standard for evaluating the presence of bone metastases.\[Ga-68\]PSMA is an investigational (experimental) drug that works by binding to Prostate Specific Membrane Antigen, which is overexpressed in prostate cancer. \[Ga-68\]PSMA is experimental because it is not approved by the Food and Drug Administration (FDA) at University Hospitals. However, FDA approval has been obtained for this study protocol by an Investigational New Drug (IND) application.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05527483
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05527483 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospitals Cleveland Medical Center
- Last refreshed: 16 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05527483.
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