Breast CancerEarly Phase 1NCT01383135
Biodistribution and Safety of the PET Probes [18F]FPRGD2 and [18F]FPPRGD2
A Early Phase 1 study testing F18-FPPRGD2 in people with Breast Cancer and Non-Small-Cell Lung Cancer, run by Stanford University at 1 site in United States.
Trial summary
The purpose of the study was to conduct a pilot test of new tracers ([18F]FPRGD2 and [18F]FPPRGD2) to define normal tracer biodistribution (where the tracer goes), stability (how much metabolises), pharmacokinetics (how much stays in which organs and for how long), and radiation dosimetry (organ radiation dose). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Non-Small-Cell Lung Cancer, Glioblastoma
- What is being tested?
- F18-FPPRGD2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Dec 2013
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers:
- Must be 18 years of age or older.
- Must have no known medical problems and have had a full medical exam within 6 months of the study.
- Must understand and voluntarily have signed an Informed Consent after its contents have been fully explained.
- Women of child bearing potential (as defined as women who are not post menopausal for 12 months or who have had no previous surgical sterilization).
- Men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 30 days after the last dose.
Show all 11Show fewer
- Cancer subjects:
- Greater than 18 years-old at the time of radiotracer administration
- Provides written informed consent
- Diagnosed with advanced non-small cell lung cancer (NSCLC), breast cancer, pancreatic cancer and glioblastoma multiforme (GBM); patients will undergo bevacizumab or Cyberknife therapy
- Able to remain still for duration of each imaging procedure (about one hour)
Who cannot join
- Less than 18 years-old at the time of radiotracer administration
- Pregnant or nursing
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
The purpose of the study was to conduct a pilot test of new tracers ([18F]FPRGD2 and [18F]FPPRGD2) to define normal tracer biodistribution (where the tracer goes), stability (how much metabolises), pharmacokinetics (how much stays in which organs and for how long), and radiation dosimetry (organ radiation dose). Healthy volunteers provided the normal biodistribution data.
The same radiopharmaceutical was also tested in breast cancer, glioblastoma multiform (brain cancer), and lung cancer.
Read the detailed description
The tracer [18F]FPRGD2 was not evaluated in this study. The protocol title was never amended to reflect this.
- Conditions
- Breast Cancer, Non-Small-Cell Lung Cancer, Glioblastoma, Other Cancers
- Being tested
- F18-FPPRGD2
- Keywords
- Healthy volunteers
- Medical subject headings
- Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F18-FPPRGD2Drug
Radiopharmaceutical administered for imaging, up to 14 mCi intravenous (IV).
| Study group | Role | What they receive |
|---|---|---|
| Healty Volunteers | Other | Normal volunteers to receive 5 to 14 mCi F18-FPPRGD2 by intravenous (IV) injection. Receives: Drug: F18-FPPRGD2 |
| Breast Cancer | Experimental | Breast cancer patients to receive 4 to 11 mCi F18-FPPRGD2 by IV injection. Receives: Drug: F18-FPPRGD2 |
| Glioblastoma Multiform (brain) | Experimental | Glioblastoma multiform patients to receive 5 to14 mCi F18-FPPRGD2 by IV injection. Receives: Drug: F18-FPPRGD2 |
| Lung Cancer | Experimental | Lung cancer patients to receive X to XX mCi F18-FPPRGD2 by IV injection. Receives: Drug: F18-FPPRGD2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tracer Dosimetry by Organ
Normal radiopharmaceutical biodistribution was analyzed visually to obtain dosimetry data in healthy volunteers. Organs with the highest radiation absorbed dose (dosimetry) are provided below. Dosimetry was calculated by drawing regions-of-interest around organs with visually appreciable radiopharmaceutical uptake greater than background and using organ-level internal dose assessment software from Vanderbuilt University (2003).
Results are reported in mSv/MBq (milli-Sieverts per mega-Bequerel) which is a measurement of the mean absorbed radiation dose within an organ.
Measured: 5 hours
F18-FPPRGD2 Time-activity at Specified Timepoints
Radiopharmaceutical pharmacokinetics describe the change in radiopharmaceutical distribution in the body (from the blood to organs, tissues, cells) over time. Radiopharmaceutical pharmacokinetics are used to determine optimal imaging time, ie, when target activity (organ or cell of interest) is greater than background activity (blood). Optimal imaging time must also be balanced with tracer bio-metabolism and radioactive decay. F18-FPPRGD2 pharmacokinetics was measured in healthy volunteers to estimate optimal imaging time. Scans were used to visually identify regions of interest (organs of F18-FPPRGD2 accumulation), and detected radiation was plotted as a measurement over time.
Measured: 30, 60, and 90 minutes post-injection
Sensitivity of F18-FPPRGD2 PET/CT in Breast Cancer
Sensitivity is the ability of a test to correctly identify patients with the disease being investigated. In this instance, how well F18-FPPRGD2 PET/CT detects true-positive patients. Sensitivity is defined as [TP/ (TP+FN)], where TP= true positive, and FN = false negative. The outcome is reported as a percentage without dispersion. A higher percentage indicates a greater probability that a lesion identified based on scan results is cancerous, and a lower percentage indicates reduced confidence in that result.
Measured: 3 hours
Specificity of F18 FPPRGD2 PET/CT in Breast Cancer
Specificity is the ability of a test to correctly identify patients who do not have the disease being investigated. In this instance, how well F18 FPPRGD2 PET/CT detects true-negative patients. Specificity is:
[TN/ (TN+FP)], where TN= true negative, and FP = false positive.
Measured: an estimated average of 3 hours
Glioblastoma Primary Tumor Response Assessed by PET Scan
Primary tumor response was assessed after 6 weeks of treatment as the change in tumor metabolism based on the maximum standardized uptake value (SUVmax) as determined by positron emission tomography (PET) scans. Decreased SUVmax correlates to a reduction of tumor metabolism, and is considered an indicator of primary tumor response. Reduction of SUVmax was determined as the change from baseline in uptake of F-18FPPRGD2. The outcome is reported as the baseline and week 6 values, with standard deviation.
Measured: Baseline and Week 6
Secondary outcomes (1)
Glioblastoma Primary Tumor Response Assessed by CT Scan
Primary tumor response was assessed after 6 weeks of treatment as the change in tumor metabolism based on the maximum standardized uptake value (SUVmax) as determined by computed tomography (CT) scans. Decreased SUVmax correlates to a reduction of tumor metabolism, and is considered an indicator of primary tumor response. Reduction of SUVmax was determined as the change from baseline in uptake of F-18FPPRGD2. The outcome is reported as the mean difference from baseline to week 6, with standard deviation.
Measured: Baseline and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startOct 2010
- Primary completionApr 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanjiv Gambhir, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01383135
- Sponsor's protocol ID
- IRB-16118
- Other IDs
- SU-09022010-6791, VAR0047
- Status last verified
- Apr 2023
- First submitted
- 31 May 2011
- Last updated
- 12 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biodistribution and Safety of the PET Probes [18F]FPRGD2 and [18F]FPPRGD2
- ClinicalTrials.gov ID
- NCT01383135
- Acronym / sponsor ID
- IRB-16118
- Conditions
- Breast Cancer, Non-Small-Cell Lung Cancer, Glioblastoma, Other Cancers
- Keywords
- Healthy volunteers
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 28 Jun 2011 (estimated)
- Results
- Posted 12 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study was to conduct a pilot test of new tracers ([18F]FPRGD2 and [18F]FPPRGD2) to define normal tracer biodistribution (where the tracer goes), stability (how much metabolises), pharmacokinetics (how much stays in which organs and for how long), and radiation dosimetry (organ radiation dose). Healthy volunteers provided the normal biodistribution data.
The same radiopharmaceutical was also tested in breast cancer, glioblastoma multiform (brain cancer), and lung cancer.
Detailed description
The tracer [18F]FPRGD2 was not evaluated in this study. The protocol title was never amended to reflect this.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healty Volunteers | Other | Drug: F18-FPPRGD2Normal volunteers to receive 5 to 14 mCi F18-FPPRGD2 by intravenous (IV) injection. |
| Breast Cancer | Experimental | Drug: F18-FPPRGD2Breast cancer patients to receive 4 to 11 mCi F18-FPPRGD2 by IV injection. |
| Glioblastoma Multiform (brain) | Experimental | Drug: F18-FPPRGD2Glioblastoma multiform patients to receive 5 to14 mCi F18-FPPRGD2 by IV injection. |
| Lung Cancer | Experimental | Drug: F18-FPPRGD2Lung cancer patients to receive X to XX mCi F18-FPPRGD2 by IV injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Must be 18 years of age or older.
- Must have no known medical problems and have had a full medical exam within 6 months of the study.
- Must understand and voluntarily have signed an Informed Consent after its contents have been fully explained.
- Women of child bearing potential (as defined as women who are not post menopausal for 12 months or who have had no previous surgical sterilization).
- Men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 30 days after the last dose.
Key exclusion criteria (2 listed)
- Less than 18 years-old at the time of radiotracer administration
- Pregnant or nursing
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 |
|---|---|---|
| F18-FPPRGD2Radiopharmaceutical administered for imaging, up to 14 mCi intravenous (IV). | Drug | Breast Cancer, Glioblastoma Multiform (brain), Healty Volunteers, Lung Cancer |
Primary outcome
Tracer Dosimetry by Organ
Time frame: 5 hours
Normal radiopharmaceutical biodistribution was analyzed visually to obtain dosimetry data in healthy volunteers. Organs with the highest radiation absorbed dose (dosimetry) are provided below. Dosimetry was calculated by drawing regions-of-interest around organs with visually appreciable radiopharmaceutical uptake greater than background and using organ-level internal dose assessment software from Vanderbuilt University (2003). Results are reported in mSv/MBq (milli-Sieverts per mega-Bequerel) which is a measurement of the mean absorbed radiation dose within an organ.
F18-FPPRGD2 Time-activity at Specified Timepoints
Time frame: 30, 60, and 90 minutes post-injection
Radiopharmaceutical pharmacokinetics describe the change in radiopharmaceutical distribution in the body (from the blood to organs, tissues, cells) over time. Radiopharmaceutical pharmacokinetics are used to determine optimal imaging time, ie, when target activity (organ or cell of interest) is greater than background activity (blood). Optimal imaging time must also be balanced with tracer bio-metabolism and radioactive decay. F18-FPPRGD2 pharmacokinetics was measured in healthy volunteers to estimate optimal imaging time. Scans were used to visually identify regions of interest (organs of F18-FPPRGD2 accumulation), and detected radiation was plotted as a measurement over time.
Sensitivity of F18-FPPRGD2 PET/CT in Breast Cancer
Time frame: 3 hours
Sensitivity is the ability of a test to correctly identify patients with the disease being investigated. In this instance, how well F18-FPPRGD2 PET/CT detects true-positive patients. Sensitivity is defined as [TP/ (TP+FN)], where TP= true positive, and FN = false negative. The outcome is reported as a percentage without dispersion. A higher percentage indicates a greater probability that a lesion identified based on scan results is cancerous, and a lower percentage indicates reduced confidence in that result.
Specificity of F18 FPPRGD2 PET/CT in Breast Cancer
Time frame: an estimated average of 3 hours
Specificity is the ability of a test to correctly identify patients who do not have the disease being investigated. In this instance, how well F18 FPPRGD2 PET/CT detects true-negative patients. Specificity is: [TN/ (TN+FP)], where TN= true negative, and FP = false positive.
Glioblastoma Primary Tumor Response Assessed by PET Scan
Time frame: Baseline and Week 6
Primary tumor response was assessed after 6 weeks of treatment as the change in tumor metabolism based on the maximum standardized uptake value (SUVmax) as determined by positron emission tomography (PET) scans. Decreased SUVmax correlates to a reduction of tumor metabolism, and is considered an indicator of primary tumor response. Reduction of SUVmax was determined as the change from baseline in uptake of F-18FPPRGD2. The outcome is reported as the baseline and week 6 values, with standard deviation.
1 secondary outcome
Glioblastoma Primary Tumor Response Assessed by CT Scan
Time frame: Baseline and Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Sanjiv Gambhir, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing F18-FPPRGD2 in people with Breast Cancer and Non-Small-Cell Lung Cancer, run by Stanford University at 1 site in United States.
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 11 inclusion and 2 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 12 Jan 2024. 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 United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Tracer Dosimetry by Organ (time frame: 5 hours). The study lists 5 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 12 Jan 2024.