F-18 Sodium Fluoride in Prostate Cancer
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | October 2010 |
| End Date: | May 2013 |
A Pilot Study of F-18 Sodium Fluoride PET/CT for Metastatic Burden Qualification in Prostate Cancer
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.
- 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.
Background:
- Evaluating response to therapy in prostate cancer is limited by the inability to
quantify bony metastatic disease
- F-18 sodium fluoride (NaF) is a PET radiopharmaceutical which localizes in regions of
bony turnover, and was the 1st bone scan agents (prior to Tc-99m MDP (methylene
diphosphonate) availability)
- Today s high sensitivity PET cameras can image the distribution of F-18 NaF as a whole
body volume and permit quantification of uptake over time. The addition of
co-registered CT increases the diagnostic accuracy for detection of metastatic disease
Primary Objective:
-To evaluate the feasibility of using NaF PET/CT to quantitatively measure the extent of
bony metastatic disease in patients with prostate cancer in patients
- To determine the intra-patient reproducibility of F-18 NaF PET/CT
- To explore the relationship between the biodistribution changes in F-18 NaF PET/CT
parameters and the clinical response
Eligibility:
- Participant must have pathology proven adenocarcinoma of the prostate.
- Participant must have
- A history of PSA > 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 (prostate specific antigen) level and known bone metastatic disease on standard of
care imaging (Tc-99m MDP bone scan, CT etc.)
- Participant must be 18 years or older and have ECOG (Eastern Cooperative Oncology
Group) Performance grade of 0 to 2
- 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.
Design:
This is a pilot, 2-arm, open label study of patients with prostate cancer. One arm will
accrue patients with known bone metastases and the second will accrue patient at risk of
developing bone metastases (30 patients per group; total enrollment 60 patients). As it is
possible that there will be different rates of bone lesion detection dependent on hormone
responsiveness of the tumors, further stratification (castrate sensitive vs. castrate
resistant tumor) may be performed to evaluate for predominant trends. All participants will
undergo a static F-18 NaF imaging session at baseline, at 4-8 months, and at 10-14 months
following enrollment (3 sessions over 1-year). Half of the participants (15 in each group)
will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in
order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over
a 1-year period. The change in bone uptake of F-18 NaF will be measured, reproducibility
determined, and preliminary comparisons with clinical response will be made.
- Evaluating response to therapy in prostate cancer is limited by the inability to
quantify bony metastatic disease
- F-18 sodium fluoride (NaF) is a PET radiopharmaceutical which localizes in regions of
bony turnover, and was the 1st bone scan agents (prior to Tc-99m MDP (methylene
diphosphonate) availability)
- Today s high sensitivity PET cameras can image the distribution of F-18 NaF as a whole
body volume and permit quantification of uptake over time. The addition of
co-registered CT increases the diagnostic accuracy for detection of metastatic disease
Primary Objective:
-To evaluate the feasibility of using NaF PET/CT to quantitatively measure the extent of
bony metastatic disease in patients with prostate cancer in patients
- To determine the intra-patient reproducibility of F-18 NaF PET/CT
- To explore the relationship between the biodistribution changes in F-18 NaF PET/CT
parameters and the clinical response
Eligibility:
- Participant must have pathology proven adenocarcinoma of the prostate.
- Participant must have
- A history of PSA > 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 (prostate specific antigen) level and known bone metastatic disease on standard of
care imaging (Tc-99m MDP bone scan, CT etc.)
- Participant must be 18 years or older and have ECOG (Eastern Cooperative Oncology
Group) Performance grade of 0 to 2
- 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.
Design:
This is a pilot, 2-arm, open label study of patients with prostate cancer. One arm will
accrue patients with known bone metastases and the second will accrue patient at risk of
developing bone metastases (30 patients per group; total enrollment 60 patients). As it is
possible that there will be different rates of bone lesion detection dependent on hormone
responsiveness of the tumors, further stratification (castrate sensitive vs. castrate
resistant tumor) may be performed to evaluate for predominant trends. All participants will
undergo a static F-18 NaF imaging session at baseline, at 4-8 months, and at 10-14 months
following enrollment (3 sessions over 1-year). Half of the participants (15 in each group)
will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in
order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over
a 1-year period. The change in bone uptake of F-18 NaF will be measured, reproducibility
determined, and preliminary comparisons with clinical response will be made.
- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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