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Safety test of inserting small gold fiducials for prostate cancer

Safety test of inserting small gold fiducials for prostate cancer - Safety test of inserting small gold fiducials for prostate cancer

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013714
Enrollment
100
Registered
2014-04-15
Start date
2014-04-15
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Solid tumor

Interventions

Au marker in 1.5mm diameter

Sponsors

Department of Radiation Oncology, Hokkaido University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Age 20-yrs old or over at the time of consent form is obtained. 2) PS is 0-3 in the criteria of ECOG. 3) Patients who are considered to be capable for insertion of Au marker (2.0mm in diameter) to the prostate gland for radiotherapy. 4) Explained well and consent to this study.

Exclusion criteria

Exclusion criteria: 1) previous history of partial or total resection of prostate gland or bladder 2) the proposed radiation treatment site had been given tolerance dose in the past 3) cannot be held rest for about 30 minutes 4) weight over 135kg 5) with serious active infections in the irradiated sites 6) with severe diabetes that uncontrolled, or treated by using insulin 7) with pulmonary arteriovenous fistula, atrial heart septal defect, ventricular heart septal defect or other shunt between right and left heart 8) severe heart disease, or some serious complications, i.e., SLE, Scleroderma, interstitial pneumonia 9) with the state of DIC, bleeding tendency, who cannot halt the anticoagulant therapy even the temporary. 10) considered that participation in this trial is difficult because of psychiatric symptoms or psychosis 11) allergic to au materials. 12) unsuitable for enrollment judged by principal investigator

Design outcomes

Primary

MeasureTime frame
Incidence of the Au marker invisibility for the usage of patient localization before and during radiotherapy

Secondary

MeasureTime frame
Incidence of the Au marker migration at one month after completion of the radiotherapy

Countries

Japan

Contacts

Public ContactShinichi Shimizu

Hokkaido University Graduate School of Medicine Department of Radiation Oncology

sshing@med.hokudai.ac.jp+81-11-706-5977

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026