Prostate Neoplasm Clinical Trial
Official title:
A Pilot Study of F-18 Sodium Fluoride PET/CT for Metastatic Burden Qualification in Prostate Cancer
Verified date | October 2017 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background:
- Sodium fluoride (NaF) is a common compound that is found in various foods and can be used
to increase bone strength. When this compound is added to a small dose of radiation (F-18),
it collects in the bones, with higher amounts in areas where the bone is rapidly changing,
such as the site of a healing fracture or a tumor. By giving F-18 NaF before a combined
positron emission tomography/ computed tomography (PET/CT) scan, researchers hope to be able
to better measure the changes in the bone that may indicate that a certain type of cancer
(such as prostate cancer) has spread to the bones.
Objectives:
- To evaluate the effectiveness of F-18 NaF in imaging studies to measure bone tumors and
their change over time and compare with clinical course, in individuals with prostate
cancer.
- To determine the smallest amount of change in the bone tumors that F-18 NaF can
accurately measure.
Eligibility:
- Men at least 18 years of age who have been diagnosed with prostate cancer and have had
imaging studies to determine whether the cancer has spread to their bones. Both patients with
and without known bone involvement will be enrolled.
Design:
- Participants will be screened with a physical examination, medical history, and imaging
studies, and will provide baseline blood samples to evaluate kidney function.
- For the study, participants will have two F-18 NaF PET/CT scans on separate days for
baseline. These repeat scans will be used to determine the amount of change that is due
to the imaging process alone (i.e. not due to the disease getting better or worse.
Participants will receive a dose of F-18 NaF intravenously, and will have PET/CT
scanning over the body (mid ear to upper thighs) over 1 hour, the body followed by a
complete whole-body PET/CT scan at approximately 2 hours after F-18 NaF injection.
Participants will be watched closely for side effects from the F-18 NaF until the scans
are done, and will be asked to drink plenty of water to void the F-18 NaF from the body
after the scans.
- As a followup study, participants will have two more F-18 NaF PET/CT scans, one 4 to 8
months after the first scans and then one 10 to 14 months after the first scans.
Participants will provide additional blood samples before the followup scans.
Status | Completed |
Enrollment | 60 |
Est. completion date | May 31, 2013 |
Est. primary completion date | May 31, 2013 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
- INCLUSION CRITERIA: Participants must have a clinical course consistent with prostate cancer and have available documentation of prostate adenocarcinoma from either the National Cancer Institute (NCI) or from an outside pathology laboratory. Participant must have: - A history of PSA of > 10ng/mL or a history of PSA doubling time of less than or equal to 6 months, and no known bone metastatic involvement on standard of care imaging (Tc-99m MDP bone scan, CT etc) OR - Any PSA level and known bone metastatic disease on standard of care imaging (Tc-99m MDP bone scan, CT etc). Ability to provide informed consent. All subjects must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed. EXCLUSION CRITERIA: Participants with severe claustrophobia unresponsive to oral anxiolytics. Subjects weighing greater than 350 lbs (weight limit for scanner table), or unable to fit within the imaging gantry. Subjects with any medical condition or other circumstances that, in the opinion of the Investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Grant FD, Fahey FH, Packard AB, Davis RT, Alavi A, Treves ST. Skeletal PET with 18F-fluoride: applying new technology to an old tracer. J Nucl Med. 2008 Jan;49(1):68-78. Epub 2007 Dec 12. Review. — View Citation
Kurdziel KA, Shih JH, Apolo AB, Lindenberg L, Mena E, McKinney YY, Adler SS, Turkbey B, Dahut W, Gulley JL, Madan RA, Landgren O, Choyke PL. The kinetics and reproducibility of 18F-sodium fluoride for oncology using current PET camera technology. J Nucl M — View Citation
Scher HI, Halabi S, Tannock I, Morris M, Sternberg CN, Carducci MA, Eisenberger MA, Higano C, Bubley GJ, Dreicer R, Petrylak D, Kantoff P, Basch E, Kelly WK, Figg WD, Small EJ, Beer TM, Wilding G, Martin A, Hussain M; Prostate Cancer Clinical Trials Working Group. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol. 2008 Mar 1;26(7):1148-59. doi: 10.1200/JCO.2007.12.4487. — View Citation
Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, Oudard S, Théodore C, James ND, Turesson I, Rosenthal MA, Eisenberger MA; TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1502-12. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Present or Not Present Bone Metastasis | Present and not present bone metastasis was determined by sodium fluoride (NaF) PET (positron emission imaging)/CT (computed tomography) imaging. Present bone metastasis is defined as greater than normal bone uptake. Not present bone metastasis is defined as physiological bone uptake of F-18 NaF on PET/CT imaging (i.e. excluding traumatic and degenerative foci of increased F-18 NaF uptake. | Single imaging sessions will be acquired at baseline, between 4-6 months and between 10-12 months on emolument. | |
Secondary | Number of Participants With Adverse Events | Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module. | date treatment consent signed to date off study, approximately 52.5 months |
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