Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-02-25 @ 8:19 PM
Study NCT ID:
NCT00989105
Status:
TERMINATED
Last Update Posted:
2012-02-28
First Post:
2009-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Technetium Tc 99m Demobesin-4 for Imaging Procedures in Patients With Prostate Cancer
Sponsor:
Cancer Research UK
Organization:
Study Overview
Official Title:
A Cancer Research UK Phase I Trial of 99mTc Demobesin-4 (a Diagnostic Radiopharmaceutical) Given Once Via Bolus Intravenous Injection for Imaging of Prostate Cancer
Status:
TERMINATED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE: Diagnostic procedures, such as technetium Tc 99m demobesin-4 followed by single-photon emission computer tomography, CT scan, and MRI, may help find prostate cancer and learn the extent of disease.
PURPOSE: This phase I trial is studying the side effects of technetium Tc 99m demobesin-4 and to see how well it works for imaging procedures in patients with prostate cancer.
PURPOSE: This phase I trial is studying the side effects of technetium Tc 99m demobesin-4 and to see how well it works for imaging procedures in patients with prostate cancer.
Detailed Description:
OBJECTIVES:
Primary
* To assess the safety of technetium Tc 99m (\^99mTc) demobesin-4 (DB4) in patients with prostate cancer.
* To assess the biodistribution of \^99mTc DB4 in these patients.
* To assess the pharmacokinetics of \^99mTc DB4 in these patients.
Secondary
* To assess the performance of \^99mTc DB4 in detecting metastatic spread of prostate cancer in these patients.
Tertiary
* To compare uptake of \^99mTc DB4 with levels of expression in gastrin-releasing peptide receptor in prostate tumor samples and lymph node specimens.
OUTLINE: Patients are stratified according to diagnosis (cancer confined to prostate vs locally advanced disease vs metastatic disease).
Patients receive technetium Tc 99m (\^99mTc) demobesin-4 (DB4) IV bolus over 1 minute and undergo imaging by single photon emission computer tomography, CT scan, and/or MRI up to 3 hours after infusion. Some patients undergo radical prostatectomy or surgical pelvic lymph node biopsies.
Blood and urine samples are collected at 5, 10, 20, 30, and 45 minutes at baseline and at 1, 2, 3, 4, and 6 hours after \^99mTc DB4 IV infusion for pharmacokinetic studies. Tumor tissue samples obtained during radical prostatectomy and surgical lymph node biopsies are analyzed for gastrin-releasing peptide receptor by IHC.
After completion of study intervention, patients are followed for up to 28 days.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
Primary
* To assess the safety of technetium Tc 99m (\^99mTc) demobesin-4 (DB4) in patients with prostate cancer.
* To assess the biodistribution of \^99mTc DB4 in these patients.
* To assess the pharmacokinetics of \^99mTc DB4 in these patients.
Secondary
* To assess the performance of \^99mTc DB4 in detecting metastatic spread of prostate cancer in these patients.
Tertiary
* To compare uptake of \^99mTc DB4 with levels of expression in gastrin-releasing peptide receptor in prostate tumor samples and lymph node specimens.
OUTLINE: Patients are stratified according to diagnosis (cancer confined to prostate vs locally advanced disease vs metastatic disease).
Patients receive technetium Tc 99m (\^99mTc) demobesin-4 (DB4) IV bolus over 1 minute and undergo imaging by single photon emission computer tomography, CT scan, and/or MRI up to 3 hours after infusion. Some patients undergo radical prostatectomy or surgical pelvic lymph node biopsies.
Blood and urine samples are collected at 5, 10, 20, 30, and 45 minutes at baseline and at 1, 2, 3, 4, and 6 hours after \^99mTc DB4 IV infusion for pharmacokinetic studies. Tumor tissue samples obtained during radical prostatectomy and surgical lymph node biopsies are analyzed for gastrin-releasing peptide receptor by IHC.
After completion of study intervention, patients are followed for up to 28 days.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: