Prostate CancerNCT04340765
18F-fluorocholine and 18F-fluoride PET in Prostate Cancer
A study testing 18F-fluorocholine in people with Prostate Cancer and Fluorocholine, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial summary
Prostate cancer remains to be a public health problem around the world. For patients with prostate cancer, diphosphonate bone scintigraphy (BS) and pelvic tomographic imaging are major imaging tools to evaluate the disease spread. Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Prostate Cancer, Fluorocholine
- What is being tested?
- 18F-fluorocholine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are pathologically diagnosed with prostate adenocarcinoma.
- Received NaF PET/CT.
Who cannot join
- Diagnosed to have multiple cancers
- Younger than 20-year-old
- Known allergic to investigational drug
- The patients is classified as not suited for the exam by the investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Metastatic Lesions From Prostate Carcinoma With 18F-NaF and 18F-Fluorocholine PET/CT
Prostate cancer remains to be a public health problem around the world. For patients with prostate cancer, diphosphonate bone scintigraphy (BS) and pelvic tomographic imaging are major imaging tools to evaluate the disease spread. However, the conventional image modalities have only limited sensitivity and specificity. New imaging tracer with 18F-fluorocholine (18F-FCH) and old radiopharmaceuticals with NaF has showed promising results in detecting prostate cancers over bone scan. Nevertheless, the diagnostic performance of each tool has less been compared.
The goal of this study is to compare the diagnostic performance of 18F-FCH PET/CT and NaF PET/CT for prostate cancer patients.
The investigators prospectively enroll patients with the pathological diagnosis of prostate cancer and intended to receive radionuclide bone image. The patients will receive NaF PET/CT and 18F-FCH PET/CT. Each image will be evaluated by experienced interpreter for abnormal uptake suspicious for cancer spreading. The reference standard will be a combination of tissue correlation, imaging, laboratory and clinical data. Diagnostic performance of both PET/CT scans will be measured and calculated.
Read the detailed description
The investigators conducted a prospective study to investigate the performance of 18F-choline (FCH) PET/CT and 18F-NaF PET in the patients with prostate adenocarcinoma.
18F-NaF PET imaging protocol: Fasting is not needed before radiotracer injection. No specific drug restriction is needed. Scan will be conduced by using a PET/CT unit (Discovery ST; GE Medical Systems, Milwaukee,Wis), and scans will be interpreted on a work station with the use of compatible software (Xeleris).
An indwelling intravenous catheter connected to an infusion line and an saline syringe will be set on each patient. 18F-NaF (148 +/- 10% MBq) will be injected intravenously through the infusion line and will be flushed by saline. NaF PET/CT scan acquisition is to be taken 30 minutes after radiotracer injection. The PET/CT (120 mA, 120 kVp) scan field will cover from vertex to toe.
Image analysis: Two nuclear medicine physicians assess the NaF PET/CT images. The investigators have access to the patients' history and interpreted individually by each reader, with disagreements to be resolved by consensus. Uptake in the focus will be evaluated of the likelihood of cancer in 5-graded scale. 0. No cancer or definitely no pathologic aspect; 1. Probably benign lesion; 2. Equivocal lesion; 3. Probably cancer; 4. Most probably cancer. For the determination of a diagnosis, score 0 and 1 are considered a negative result and 2 to 4 a positive result.
18F-FCH PET imaging protocol: The 18F-FCH PET will be arranged within 6 weeks after NaF PET. Fasting is not needed before radiotracer injection. No specific drug restriction is needed. Scan will be conduced by using a PET/CT unit (Discovery ST; GE Medical Systems, Milwaukee,Wis), and scans will be interpreted on a work station with the use of compatible software (Xeleris).
An indwelling intravenous catheter connected to an infusion line and an saline syringe will be set on each patient. 18F-FCH (185 +/- 10% MBq) will be injected intravenously through the infusion line and will be flushed by saline. The injected 18F-FCH dose, injection time, post-injection residual activity, time of start imaging and time of end imaging will be recorded on case report form. 18F-FCH PET/CT scan acquisition is to be taken 5 to 10 minutes after radiotracer injection. The PET/CT (80-120 mA, 120 kVp) scan field will cover from skull to mid-thigh. The 18F-FCH PET/CT scan time will require 35-40 minutes.
Image analysis: Two nuclear medicine physicians assess the 18F-FCH PET/CT images. The investigators have access to the patients' history and interpreted individually by each reader, with disagreements to be resolved by consensus. Uptake in the focus will be evaluated of the likelihood of cancer in 5-graded scale. 0. No cancer or definitely no pathologic aspect; 1. Probably benign lesion; 2. Equivocal lesion; 3. Probably cancer; 4. Most probably cancer. For the determination of a diagnosis, score 0 and 1 are considered a negative result and 2 to 4 a positive result.
Reference standard: The skeletal lesion will be evaluated by both 18F-FCH PET/CT and NaF PET/CT findings. Congruent positive lesion and congruent negative will be defined as true positive and true negative, respectively. A third image study (MRI or CT) will be introduced for those with incongruent and ambiguous PET features. Biopsy will be reserved for those lesions with undetermined results after third image study.
The extra-skeletal cancerous lesions are theoretically be detected on 18F-FCH PET/CT only, thus, the reference modality will not include NaF PET/CT. The prostate bed in patients with either positive or negative imaging studies will be investigated with pelvic MRI. Patients with abnormal foci in pelvic and abdominal extraprostatic tissue at imaging will be investigated by using pelvic MRI as well. If lesions on MRI and 18F-FCH PET/CT are both positive, the lesions will be treated as malignancy. Patients with lesions on 18F-FCH PET/CT along will be evaluated by the investigator and co-investigators to decide if the patient will receive biopsy or not. The lesion will be confirmed to be malignant if positive biopsy results. The patient will receive further follow-up by MRI and serum PSA after 6 and 12 months if the patient is not suitable for biopsy. The lesion will be confirmed to be malignant if substantial growth in lesion size or increase serum PSA. Patients with both negative MRI and negative 18F-FCH PET/CT will be evaluated by the aforementioned follow-up schedule as well. If the initial pelvic MRI is positive for malignancy and the 18F-FCH PET/CT is negative, the lesion will be treated as positive for malignancy. However, the patient still need the 6 and 12 months of follow-up to confirm the nature of the lesion. Biopsy will be reserved for those patients with undetermined results despite vigorous image studies.
- Conditions
- Prostate Cancer, Fluorocholine
- Being tested
- 18F-fluorocholine
- Keywords
- Prostate cancer, NaF, Bone scan, 18F-Fluorocholine, PET
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-fluorocholineDrug
Also called 18F-NaF
Dual phase 18F-fluorocholine PET/CT
| Study group | Role | What they receive |
|---|---|---|
| 18F-fluorocholine PET/CT | Experimental | 18F-fluorocholine PET/CT Receives: Drug: 18F-fluorocholine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivities of 18F-fluorocholine PET/CT and NaF PET/CT
The lesion-based sensitivities of these two image modalities (The number of true positive image findings/The number of confirmed metastasis)
Measured: 6 weeks
The specificities of 18F-fluorocholine PET/CT and NaF PET/CT
The lesion-based specificities of these two image modalities (The number of true negative image findings/The number of confirmed e benign lesion)
Measured: 6 weeks
Secondary outcomes (1)
Extraskeletal metastatic lesions detected by 18F-fluorocholine PET/CT
To calculated the extraskeletal metastatic lesion that is detected by 18F-fluorocholine PET/CT
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start1 Feb 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The patients will receive both 18F-fluorocholine PET and NaF PET
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Hung Chen, M.D., Principal investigator, Hualien Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340765
- Sponsor's protocol ID
- IRB106-65-A
- Status last verified
- Apr 2020
- First submitted
- 7 Apr 2020
- Last updated
- 13 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Metastatic Lesions From Prostate Carcinoma With 18F-NaF and 18F-Fluorocholine PET/CT
- ClinicalTrials.gov ID
- NCT04340765
- Acronym / sponsor ID
- IRB106-65-A
- Conditions
- Prostate Cancer, Fluorocholine
- Keywords
- Prostate cancer, NaF, Bone scan, 18F-Fluorocholine, PET
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 10 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prostate cancer remains to be a public health problem around the world. For patients with prostate cancer, diphosphonate bone scintigraphy (BS) and pelvic tomographic imaging are major imaging tools to evaluate the disease spread. However, the conventional image modalities have only limited sensitivity and specificity. New imaging tracer with 18F-fluorocholine (18F-FCH) and old radiopharmaceuticals with NaF has showed promising results in detecting prostate cancers over bone scan. Nevertheless, the diagnostic performance of each tool has less been compared.
The goal of this study is to compare the diagnostic performance of 18F-FCH PET/CT and NaF PET/CT for prostate cancer patients.
The investigators prospectively enroll patients with the pathological diagnosis of prostate cancer and intended to receive radionuclide bone image. The patients will receive NaF PET/CT and 18F-FCH PET/CT. Each image will be evaluated by experienced interpreter for abnormal uptake suspicious for cancer spreading. The reference standard will be a combination of tissue correlation, imaging, laboratory and clinical data. Diagnostic performance of both PET/CT scans will be measured and calculated.
Detailed description
The investigators conducted a prospective study to investigate the performance of 18F-choline (FCH) PET/CT and 18F-NaF PET in the patients with prostate adenocarcinoma.
18F-NaF PET imaging protocol: Fasting is not needed before radiotracer injection. No specific drug restriction is needed. Scan will be conduced by using a PET/CT unit (Discovery ST; GE Medical Systems, Milwaukee,Wis), and scans will be interpreted on a work station with the use of compatible software (Xeleris).
An indwelling intravenous catheter connected to an infusion line and an saline syringe will be set on each patient. 18F-NaF (148 +/- 10% MBq) will be injected intravenously through the infusion line and will be flushed by saline. NaF PET/CT scan acquisition is to be taken 30 minutes after radiotracer injection. The PET/CT (120 mA, 120 kVp) scan field will cover from vertex to toe.
Image analysis: Two nuclear medicine physicians assess the NaF PET/CT images. The investigators have access to the patients' history and interpreted individually by each reader, with disagreements to be resolved by consensus. Uptake in the focus will be evaluated of the likelihood of cancer in 5-graded scale. 0. No cancer or definitely no pathologic aspect; 1. Probably benign lesion; 2. Equivocal lesion; 3. Probably cancer; 4. Most probably cancer. For the determination of a diagnosis, score 0 and 1 are considered a negative result and 2 to 4 a positive result.
18F-FCH PET imaging protocol: The 18F-FCH PET will be arranged within 6 weeks after NaF PET. Fasting is not needed before radiotracer injection. No specific drug restriction is needed. Scan will be conduced by using a PET/CT unit (Discovery ST; GE Medical Systems, Milwaukee,Wis), and scans will be interpreted on a work station with the use of compatible software (Xeleris).
An indwelling intravenous catheter connected to an infusion line and an saline syringe will be set on each patient. 18F-FCH (185 +/- 10% MBq) will be injected intravenously through the infusion line and will be flushed by saline. The injected 18F-FCH dose, injection time, post-injection residual activity, time of start imaging and time of end imaging will be recorded on case report form. 18F-FCH PET/CT scan acquisition is to be taken 5 to 10 minutes after radiotracer injection. The PET/CT (80-120 mA, 120 kVp) scan field will cover from skull to mid-thigh. The 18F-FCH PET/CT scan time will require 35-40 minutes.
Image analysis: Two nuclear medicine physicians assess the 18F-FCH PET/CT images. The investigators have access to the patients' history and interpreted individually by each reader, with disagreements to be resolved by consensus. Uptake in the focus will be evaluated of the likelihood of cancer in 5-graded scale. 0. No cancer or definitely no pathologic aspect; 1. Probably benign lesion; 2. Equivocal lesion; 3. Probably cancer; 4. Most probably cancer. For the determination of a diagnosis, score 0 and 1 are considered a negative result and 2 to 4 a positive result.
Reference standard: The skeletal lesion will be evaluated by both 18F-FCH PET/CT and NaF PET/CT findings. Congruent positive lesion and congruent negative will be defined as true positive and true negative, respectively. A third image study (MRI or CT) will be introduced for those with incongruent and ambiguous PET features. Biopsy will be reserved for those lesions with undetermined results after third image study.
The extra-skeletal cancerous lesions are theoretically be detected on 18F-FCH PET/CT only, thus, the reference modality will not include NaF PET/CT. The prostate bed in patients with either positive or negative imaging studies will be investigated with pelvic MRI. Patients with abnormal foci in pelvic and abdominal extraprostatic tissue at imaging will be investigated by using pelvic MRI as well. If lesions on MRI and 18F-FCH PET/CT are both positive, the lesions will be treated as malignancy. Patients with lesions on 18F-FCH PET/CT along will be evaluated by the investigator and co-investigators to decide if the patient will receive biopsy or not. The lesion will be confirmed to be malignant if positive biopsy results. The patient will receive further follow-up by MRI and serum PSA after 6 and 12 months if the patient is not suitable for biopsy. The lesion will be confirmed to be malignant if substantial growth in lesion size or increase serum PSA. Patients with both negative MRI and negative 18F-FCH PET/CT will be evaluated by the aforementioned follow-up schedule as well. If the initial pelvic MRI is positive for malignancy and the 18F-FCH PET/CT is negative, the lesion will be treated as positive for malignancy. However, the patient still need the 6 and 12 months of follow-up to confirm the nature of the lesion. Biopsy will be reserved for those patients with undetermined results despite vigorous image studies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The patients will receive both 18F-fluorocholine PET and NaF PET
| Arm | Type | Receives |
|---|---|---|
| 18F-fluorocholine PET/CT | Experimental | Drug: 18F-fluorocholine18F-fluorocholine PET/CT |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients are pathologically diagnosed with prostate adenocarcinoma.
- Received NaF PET/CT.
Key exclusion criteria (4 listed)
- Diagnosed to have multiple cancers
- Younger than 20-year-old
- Known allergic to investigational drug
- The patients is classified as not suited for the exam by the investigators.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-fluorocholineAlso: 18F-NaFDual phase 18F-fluorocholine PET/CT | Drug | 18F-fluorocholine PET/CT |
Primary outcome
The sensitivities of 18F-fluorocholine PET/CT and NaF PET/CT
Time frame: 6 weeks
The lesion-based sensitivities of these two image modalities (The number of true positive image findings/The number of confirmed metastasis)
The specificities of 18F-fluorocholine PET/CT and NaF PET/CT
Time frame: 6 weeks
The lesion-based specificities of these two image modalities (The number of true negative image findings/The number of confirmed e benign lesion)
1 secondary outcome
Extraskeletal metastatic lesions detected by 18F-fluorocholine PET/CT
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Hung Chen, M.D. principal investigator
Hualien Tzu Chi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-fluorocholine in people with Prostate Cancer and Fluorocholine, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivities of 18F-fluorocholine PET/CT and NaF PET/CT (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2020.