Studies
| Study First Submitted Date | 2021-07-27 |
| Study First Posted Date | 2021-08-12 |
| Last Update Posted Date | 2023-05-19 |
| Verification Month Year | May 2023 |
| Verification Date | 2023-05-31 |
| Last Update Posted Date | 2023-05-19 |
Detailed Descriptions
| Sequence: | 20814716 |
| Description | 68Ga PSMA-11 PET/CT offers higher detection rate of metastatic disease in prostate cancer than the current standard of care of computed tomography (CT), magnetic resonance imaging (MRI), and bone scintigraphy usually used in staging and restaging prostate cancer. Furthermore, 68Ga PSMA-11 PET/CT offers a higher detection rate of primary and metastatic prostate cancer compared to other available radiotracers used for prostate cancer. It additionally offers enhanced imaging characteristics of greater sensitivity at lower prostate specific antigen (PSA) values and higher target to background ratios than currently available radiotracers. For these reasons, we feel that expanded access to 68Ga PSMA-11 offers better patient care at comparable cost to standard imaging. The population to be treated consists of men in whom metastatic or recurrent prostate cancer is suspected. Patients will be recruited primarily from the clinical practices of the University of Texas Southwestern Medical Center (UTSW) and Parkland Health and Hospital System. Additional patients may be referred for recruitment from physicians outside UTSW. Each patient will receive an IV injection of 68Ga PSMA-11 as a bolus intravenous injection. Depending on patient medical history and Radiology physician preference, the patient may also be injected with 20 milligrams (mg) of furosemide to encourage urination, and the patient will void immediately prior to getting on the scan table. Patients will be scanned on a PET/CT scanner. The patient will be positioned with arms elevated above the head. |
Facilities
| Sequence: | 200882490 |
| Status | Available |
| Name | UT Southwestern Medical Center |
| City | Dallas |
| State | Texas |
| Zip | 75390 |
| Country | United States |
Facility Contacts
| Sequence: | 28240951 |
| Facility Id | 200882490 |
| Contact Type | primary |
| Name | Kelli Key, PhD |
| Kelli.Key@UTSouthwestern.edu | |
| Phone | 214-648-8152 |
Facility Investigators
| Sequence: | 18415996 |
| Facility Id | 200882490 |
| Role | Principal Investigator |
| Name | Neil Rofsky, MD, MHA |
Browse Interventions
| Sequence: | 96417759 | Sequence: | 96417760 | Sequence: | 96417761 |
| Mesh Term | Gallium 68 PSMA-11 | Mesh Term | Radiopharmaceuticals | Mesh Term | Molecular Mechanisms of Pharmacological Action |
| Downcase Mesh Term | gallium 68 psma-11 | Downcase Mesh Term | radiopharmaceuticals | Downcase Mesh Term | molecular mechanisms of pharmacological action |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
| Sequence: | 52408549 | Sequence: | 52408550 | Sequence: | 52408551 |
| Name | Prostate Cancer | Name | Prostate Cancer Metastatic | Name | Prostate Cancer Recurrent |
| Downcase Name | prostate cancer | Downcase Name | prostate cancer metastatic | Downcase Name | prostate cancer recurrent |
Id Information
| Sequence: | 40326423 |
| Id Source | org_study_id |
| Id Value | STU-2021-0291 |
Countries
| Sequence: | 42749496 |
| Name | United States |
| Removed | False |
Interventions
| Sequence: | 52716663 | Sequence: | 52716664 |
| Intervention Type | Drug | Intervention Type | Procedure |
| Name | 68Ga-PSMA-11 | Name | Positron Emission Tomography/Computed Tomography |
| Description | Injection of 68Ga PSMA-11 | Description | PET/CT scan after 68Ga PSMA-11 injection |
Keywords
| Sequence: | 80189384 | Sequence: | 80189385 | Sequence: | 80189386 |
| Name | Gallium-68 | Name | PSMA-11 | Name | PET/CT |
| Downcase Name | gallium-68 | Downcase Name | psma-11 | Downcase Name | pet/ct |
Browse Conditions
| Sequence: | 194387863 | Sequence: | 194387864 | Sequence: | 194387865 | Sequence: | 194387866 | Sequence: | 194387867 | Sequence: | 194387868 | Sequence: | 194387869 | Sequence: | 194387870 | Sequence: | 194387871 | Sequence: | 194387872 |
| Mesh Term | Prostatic Neoplasms | Mesh Term | Genital Neoplasms, Male | Mesh Term | Urogenital Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Genital Diseases, Male | Mesh Term | Genital Diseases | Mesh Term | Urogenital Diseases | Mesh Term | Prostatic Diseases | Mesh Term | Male Urogenital Diseases |
| Downcase Mesh Term | prostatic neoplasms | Downcase Mesh Term | genital neoplasms, male | Downcase Mesh Term | urogenital neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | genital diseases, male | Downcase Mesh Term | genital diseases | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | prostatic diseases | Downcase Mesh Term | male urogenital diseases |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48540127 |
| Agency Class | OTHER |
| Lead Or Collaborator | lead |
| Name | Dana Mathews |
Overall Officials
| Sequence: | 29408542 |
| Role | Principal Investigator |
| Name | Orhan K Oz, MD, PhD |
| Affiliation | UT Southwestern Medical Center |
Central Contacts
| Sequence: | 12071439 |
| Contact Type | primary |
| Name | Kelli Key, PhD |
| Phone | 214-648-8152 |
| Kelli.Key@UTSouthwestern.edu | |
| Role | Contact |
Eligibilities
| Sequence: | 30902012 |
| Gender | Male |
| Minimum Age | 18 Years |
| Maximum Age | N/A |
| Criteria | Inclusion Criteria: One of the following: Patients with suspected recurrence based on elevated serum prostate specific antigen (PSA) level. Patients with suspected metastasis who are candidates for initial definitive therapy. Patients must be able to lie still for approximately 20 – 40 minutes for the PET/CT scans. Patients must be deemed medically stable by their treating physician. Patients must have the ability and willingness to sign a written informed consent. Exclusion Criteria: Patients must not weigh more than the maximum weight limit for the PET/CT scanner table (> 225 kilograms or 500 pounds). Patients must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga PSMA-11. Patients must not be claustrophobic. |
| Gender Based | True |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 254155895 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2021 |
| Were Results Reported | False |
| Has Us Facility | True |
| Has Single Facility | True |
| Minimum Age Num | 18 |
| Minimum Age Unit | Years |
Intervention Other Names
| Sequence: | 26787134 |
| Intervention Id | 52716664 |
| Name | PET/CT |
Responsible Parties
| Sequence: | 29014371 |
| Responsible Party Type | Sponsor-Investigator |
| Name | Dana Mathews |
| Title | Professor |
| Affiliation | University of Texas Southwestern Medical Center |