SarcomaEarly Phase 1K5NCT00743353
Exploratory, Phase 0 Study of Positron Emission Tomography (PET) Imaging Agent, F-18 RGD-K5
A Early Phase 1 study testing F-18 RGD-K5 in people with Sarcoma and Melanoma, run by Siemens Molecular Imaging at 1 site in United States.
Trial summary
The purpose of this research study is to get information from volunteers without cancer and patients with cancer who have received a new investigational study agent called, "[F-18] RGDK5," to evaluate biodistribution and dosimetry for the study agent and determine F-18 RGD-K5 uptake in angiogenic tumor. the system. Read more about this study
- Who is it for?
- Ages 18 days and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcoma, Melanoma, Lung Cancer
- What is being tested?
- F-18 RGD-K5
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Jan 2009
- Phase
- Early Phase 1
- 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 18 days and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- For Normal Volunteers
- Subject is ≥ 18 years old at the time of investigational product administration (Subject is male or female of any race / ethnicity)
- Subject or subject's legally acceptable representative provides informed consent
- Subject is capable of complying with study procedures
- Subject is capable of communicating with study personnel
- For Cancer Subjects (same first four bullets as 'normals')
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- Subject must have had a diagnostic imaging study and is suspected of having a primary or metastatic tumor(s) ( > 2 cm, except breast tumor)-sarcoma; melanoma; lung cancer [including small cell and non-small cell lung cancer (NSCL)]; high grade glioma (including glioblastoma multi-forms), anaplastic astrocytoma, and anaplastic oligodendroglioma; breast carcinomas, and head and neck tumors, including laryngeal squamous cell carcinoma
- Subject is scheduled to have a clinical [F-18]FDG PET scan within ± 7 days (with no interventions between the two PET scans) of the investigational, [F-18]RGD-K5 PET scan
- Subject is scheduled to undergo resection or biopsy of the target tumor as a result of routine clinical treatment
- Subject has not received any anti-angiogenic agents (e.g. bevacizumab, sorafenib, sunitinib) within 10 days prior to PET/CT imaging
- Subject has laboratory test results within the following ranges:
- AST(SGOT)/ALT(SGPT) ≤ 2.5 x institutional upper limits of normal
- Serum creatinine ≤ 1.5 institutional upper limits of normal
- Platelet count of > 75,000x106/L
- Hemoglobin value of > 9 g/dL
- ANC > 1.2 x 106 /mL
Who cannot join
- Subject is < 18 at the time of investigational product administration
- Female subject is pregnant or nursing:
- by testing on site at the institution (serum or urine ßHCG) within 24 hours prior to the investigational product administration
- Subject is unable to remain still for duration of imaging procedure
- Subject has a history of renal disease
- Subject has previously received [F-18]RGD-K5 at any time, or any other investigational product in the past 30 days or will receive any other investigational product within 48 hours after the [F-18]RGD-K5 injection
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- Subject has not been involved in an investigative, radioactive research procedure or therapeutic procedure within the past 6 months
- Subject has any other condition or personal circumstance including severe claustrophobia, severe dyspnea, severe back pain etc, that, in the judgment of the investigator, might interfere with the collection of complete good quality data
- Subject has a history of significant prescription or non-prescription drug, or alcohol abuse, including but not limited to marijuana, cocaine, heroin or derivatives.
- For Cancer Subjects (first three bullets the same as 'normals')
- Subject is < 18 at the time of investigational product administration
- Female subject is pregnant or nursing:
- by testing on site at the institution (serum or urine ßHCG)
- Subject is unable to remain still for duration of imaging procedure
- Subject has known hyper or hypo-coagulation syndromes. (e.g., Protein C, S deficiency, Hemophilia A/B/C, Factor-V Leiden, etc.)
- Subject has previously received [F-18]RGD-K5 at any time, or any other investigational product in the past 30 days or will receive any other investigational product within 48 hours after the [F-18]RGD-K5 injection.
- Subject has inadequate tumor size (< 2 cm , except for breast tumor) or volume to allow for biopsy
- Subject has any other condition or personal circumstance including severe claustrophobia, severe dyspnea, severe back pain etc, that, in the judgment of the investigator, might interfere with the collection of complete good quality data
- Subject has a history of significant prescription or non-prescription drug, or alcohol abuse, including but not limited to marijuana, cocaine, heroin or derivatives.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: An Exploratory, Multi-Center, Open Label, Non-Randomized Study of F-18 RGD-K5
The purpose of this research study is to get information from volunteers without cancer and patients with cancer who have received a new investigational study agent called, "[F-18] RGDK5," to evaluate biodistribution and dosimetry for the study agent and determine F-18 RGD-K5 uptake in angiogenic tumor. the system.
Read the detailed description
[F-18]RGD-K5 is being investigated as a diagnostic radiopharmaceutical for the detection and localization of angiogenesis tissue or lesions supporting the application and role of integrins in anti-angiogenic therapies to benefit patients with cancer and inflammatory diseases.
The primary objectives of this exploratory study are:
- To gain information on biodistribution of [F-18]RGD-K5, and to evaluate the PET images with [F-18]RGD-K5 for resolution, signal to background ratio and for the detection and localization of angiogenesis tissue. This Exploratory Investigational New Drug (EIND) study is designed to obtain preliminary imaging and fundamental biodistribution, metabolism and safety information to demonstrate early proof of concept. The information collected under this study will not be used for diagnostic purposes, to assess the subject's response to therapy, or for clinical management for the subject.
- Conditions
- Sarcoma, Melanoma, Lung Cancer, Breast Cancer, High Grade Gliomas
- Being tested
- F-18 RGD-K5
- Keywords
- laryngeal, squamous cell, anaplastic astrocytoma, oligodendroglioma, glioblastoma multiforme
- Medical subject headings
- Sarcoma, Melanoma, Lung Neoplasms, Breast Neoplasms, Laryngeal Diseases, Astrocytoma, Oligodendroglioma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-18 RGD-K5Drug
Study Drug F-18 RGD-K5 administered for diagnostic PET Imaging to be observed for a maximum of 4 hours, followed by 24 hour follow up
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 16 subjects to be enrolled; Study Drug F-18 RGD-K5 administered for diagnostic PET Imaging to be observed for a maximum of 4 hours, followed by 24 hour follow up Receives: Drug: F-18 RGD-K5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To collect bio-distribution data to calculate dosimetry values in normals and obtain and evaluate PET images in cancer subjects for resolution of [F-18]RGD-K5
Measured: imaging study-participation only days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcomaStudies 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Siemens Molecular Imaging
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael Yu, MD, Principal investigator, Fox Chase Cancer Center, Dept of Nuclear Medicine, 333 Cottman Ave, Phila, PA 19111
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00743353
- Sponsor's protocol ID
- K5-100
- Acronym
- K5
- Status last verified
- Jan 2009
- First submitted
- 26 Aug 2008
- Last updated
- 2 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Doss M, Kolb HC, Zhang JJ, Belanger MJ, Stubbs JB, Stabin MG, Hostetler ED, Alpaugh RK, von Mehren M, Walsh JC, Haka M, Mocharla VP, Yu JQ. Biodistribution and radiation dosimetry of the integrin marker 18F-RGD-K5 determined from whole-body PET/CT in monkeys and humans. J Nucl Med. 2012 May;53(5):787-95. doi: 10.2967/jnumed.111.088955. Epub 2012 Apr 12.
PubMed 22499613
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Multi-Center, Open Label, Non-Randomized Study of F-18 RGD-K5
- ClinicalTrials.gov ID
- NCT00743353
- Acronym / sponsor ID
- K5 / K5-100
- Conditions
- Sarcoma, Melanoma, Lung Cancer, Breast Cancer, High Grade Gliomas
- Keywords
- laryngeal, squamous cell, anaplastic astrocytoma, oligodendroglioma, glioblastoma multiforme
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Siemens Molecular ImagingIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 28 Aug 2008 (estimated)
- 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.
The purpose of this research study is to get information from volunteers without cancer and patients with cancer who have received a new investigational study agent called, "[F-18] RGDK5," to evaluate biodistribution and dosimetry for the study agent and determine F-18 RGD-K5 uptake in angiogenic tumor. the system.
Detailed description
[F-18]RGD-K5 is being investigated as a diagnostic radiopharmaceutical for the detection and localization of angiogenesis tissue or lesions supporting the application and role of integrins in anti-angiogenic therapies to benefit patients with cancer and inflammatory diseases.
The primary objectives of this exploratory study are:
- To gain information on biodistribution of [F-18]RGD-K5, and to evaluate the PET images with [F-18]RGD-K5 for resolution, signal to background ratio and for the detection and localization of angiogenesis tissue. This Exploratory Investigational New Drug (EIND) study is designed to obtain preliminary imaging and fundamental biodistribution, metabolism and safety information to demonstrate early proof of concept. The information collected under this study will not be used for diagnostic purposes, to assess the subject's response to therapy, or for clinical management for the subject.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: F-18 RGD-K516 subjects to be enrolled; Study Drug F-18 RGD-K5 administered for diagnostic PET Imaging to be observed for a maximum of 4 hours, followed by 24 hour follow up |
Who may qualify
- Ages
- 18 days and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- For Normal Volunteers
- Subject is ≥ 18 years old at the time of investigational product administration (Subject is male or female of any race / ethnicity)
- Subject or subject's legally acceptable representative provides informed consent
- Subject is capable of complying with study procedures
- Subject is capable of communicating with study personnel
Key exclusion criteria (19 listed)
- Subject is < 18 at the time of investigational product administration
- Female subject is pregnant or nursing:
- by testing on site at the institution (serum or urine ßHCG) within 24 hours prior to the investigational product administration
- Subject is unable to remain still for duration of imaging procedure
- Subject has a history of renal disease
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 |
|---|---|---|
| F-18 RGD-K5Study Drug F-18 RGD-K5 administered for diagnostic PET Imaging to be observed for a maximum of 4 hours, followed by 24 hour follow up | Drug | A |
Primary outcome
To collect bio-distribution data to calculate dosimetry values in normals and obtain and evaluate PET images in cancer subjects for resolution of [F-18]RGD-K5
Time frame: imaging study-participation only days
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 2 Feb 2009.
- Derived from this study: PubMed 22499613Doss M, Kolb HC, Zhang JJ, Belanger MJ, Stubbs JB, Stabin MG, Hostetler ED, Alpaugh RK, von Mehren M, Walsh JC, Haka M, Mocharla VP, Yu JQ. Biodistribution and radiation dosimetry of the integrin marker 18F-RGD-K5 determined from whole-body PET/CT in monkeys and humans. J Nucl Med. 2012 May;53(5):787-95. doi: 10.2967/jnumed.111.088955. Epub 2012 Apr 12.
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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.
Michael Yu, MD principal investigator
Fox Chase Cancer Center, Dept of Nuclear Medicine, 333 Cottman Ave, Phila, PA 19111
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 F-18 RGD-K5 in people with Sarcoma and Melanoma, run by Siemens Molecular Imaging 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 16 inclusion and 19 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 2 Feb 2009. 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?
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?
To collect bio-distribution data to calculate dosimetry values in normals and obtain and evaluate PET images in cancer subjects for resolution of [F-18]RGD-K5 (time frame: imaging study-participation only days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00743353, which also lists 1 linked publication.
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 2 Feb 2009.