NCT05614518 is a Phase 3 clinical trial of Sodium Fluoride F-18 Injection in Bone Metastases, sponsored by HTA Co., Ltd..

Who is sponsoring NCT05614518?

NCT05614518 is sponsored by HTA Co., Ltd..

What drugs are being tested in NCT05614518?

Interventions in NCT05614518: Sodium Fluoride F-18 Injection, Technetium[99mTc] Methylenediphosphonate Injection.

What condition does NCT05614518 study?

NCT05614518 studies Bone Metastases.

Is NCT05614518 still recruiting?

NCT05614518 is currently completed. Last updated 14 November 2022.

Last reviewed 2022-11-14 · How we verify

NCT05614518

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Diagnostic Performance and Safety of 18F-NaF-PET/CT in Bone Metastases Compared With 99mTc⁃MDP-BS±SPECT

Completed Phase 3 Last updated 14 November 2022

What this trial tests

Phase 3 trial testing Sodium Fluoride F-18 Injection in Bone Metastases in 280 participants. Completed in 2 June 2022.

Timeline

29 March 2021

Primary endpoint
2 June 2022

2 June 2022

Quick facts

Lead sponsor	HTA Co., Ltd.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	diagnostic
Enrollment	280
Start date	29 March 2021
Primary completion	2 June 2022
Estimated completion	2 June 2022
Sites	1 location across China

Drugs / interventions tested

Sodium Fluoride F-18 Injection — full drug profile →
Technetium[99mTc] Methylenediphosphonate Injection — full drug profile →

Conditions studied

Bone Metastases — all drugs for Bone Metastases →

Sponsor

HTA Co., Ltd. — full company profile →

Who can join

Adults 18 to 75, any sex, with Bone Metastases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial was to assess the diagnostic performance and safety of Sodium Fluoride F-18 Positron Emission Tomography / Computed Tomography (18F-NaF-PET/CT) in bone metastases of malignant tumors compared with Technetium\[99mTc\] Methylenediphosphonate Bone Scintigraphy ± Single Photon Emission Computed Tomography (99mTc-MDP-BS±SPECT). The enrolled subjects were randomly assigned to two sequences A and B at a ratio of 1:1. Within 7 days, 18F-NaF-PET/CT and 99mTc-MDP-BS±SPECT bone imaging were performed alternately. The sensitivity, specificity, positive and negative predictive value of 18F-NaF-PET/CT and 99mTc-MDP-BS±SPECT were calculated respectively based on the diagnostic data of standard of truth.

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:

Other recruiting trials for Bone Metastases

Currently open trials in the same condition.

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NCT06065449 — A Phase III Randomized Trial Comparing Stereotactic Body Radiation Therapy (SBRT) vs Conventional Palliative Radiation T · Phase 3 · recruiting
NCT06487013 — Effectiveness and Safety of ArcBlate Palliative Treatment for Patients With Painful Bone Metastases: A Pivotal Study · NA · recruiting
NCT06189079 — Arterial Embolization for the Treatment of Bone Metastases: Prospective Observational Study · recruiting

Other HTA Co., Ltd. trials

Trials by the same sponsor.

NCT06754085 — Study of 18F-Florastamin PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer · Phase 3 · recruiting
NCT07119242 — Evaluate the Diagnostic Efficacy, Pharmacokinetics and Safety of 68Ga-DOTATATE Injection PET/CT in NETs · Phase 3 · active not recruiting
NCT07057622 — A Phase III Clinical Study to Compare the Safety and Efficacy of 177Lu-DOTATATE Injection and Long-acting Oxytrexine in · Phase 3 · recruiting
NCT06593626 — A Phase I Clinical Study on the Safety and Pharmacokinetics of [18F]Florbetazine Injection · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05614518 (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 HTA Co., Ltd.
Last refreshed: 14 November 2022

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/NCT05614518.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing