Kidney NeoplasmsPhase 1/2NCT01633255
[18]F-Fluciclatide for Kidney Cancer Imaging Studies and Treatment
A Phase 1/2 study testing 18F-Fluciclatide in people with Kidney Neoplasms, run by National Cancer Institute (NCI).
Trial summary
Background: The experimental contrast agent [18]F-Fluciclatide is being tested for cancer treatment imaging studies. It is designed to show tumors in which new blood vessels are growing. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Kidney Neoplasms
- What is being tested?
- 18F-Fluciclatide
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 18 Apr 2012to 23 Apr 2014
- Phase
- Phase 1/2
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subjects (greater than or equal to18 years old), with documented renal malignancy or metastatic renal cancer, with at least one tumor greater than or equal to1 cm in diameter (not within the liver), who are scheduled for treatment using an anti-angiogenic therapy agent
- Platelet count of >100,000 times 10(6)/L, hemoglobin value of >9 g/dL, PT and an aPTT < 2 times normal limits.
- Clinically acceptable medical history, physical examination and vital signs findings during the screening period (from <4 weeks before administration of [18F] Fluciclatide); i.e. Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2.
- The subject has had no open surgical wounds in close proximity to the target lesion(s) within 10 days prior to study entry.
- The subject has not had a needle/core biopsy of the target lesion within 10 days of PET/CT imaging.
- The subject has not had radiation therapy to the region of the target lesion.
Who cannot join
- The subject is pregnant or nursing.
- The subject is being treated with doses of heparin or warfarin resulting in elevation of PT or aPTT >2 times normal.
- The subject has received any anti-angiogenic agent (e.g. bevacizumab, sorafenib, sunitinib) within 60 days prior to pre-treatment (baseline) [18F] Fluciclatide PE imaging. This stipulation does not apply after the baseline [18F] Fluciclatide PET imaging.
- The subject has any contraindication to any of the study procedures, products used or its constituents (e.g. severe claustrophobia unrelieved by oral anxiolytics).
- The subject is unable to lie still for 75 minutes.
- 2.1.2.6 The subject is known to have a history of hyper- or hypo-coagulation syndromes resulting in prolongation of bleeding parameters. Such coagulopathies include but are not limited to Von Willebrand disease, Protein C deficiency, Protein S deficiency, Hemophilia A/B/C, Factor-V Leiden, and Bernard-Soulier syndrome.
Show all 14Show fewer
- The subject has undergone a surgical procedure to the target lesion within 28 days prior to baseline [18F] Fluciclatide administration OR is scheduled to undergo a surgical procedure between the baseline and post 1-cycle [18F] Fluciclatide PET/CT.
- The subject has only bone metastasis
- ADDITIONAL EXCLUSION CRITERIA FOR SUBJECTS UNDERGOING OPTIONAL MR:
- Serum creatinine within 2 weeks prior to MRI greater than or equal to1.8mg/dl OR estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m(2).
- The subject has known allergy to gadolinium
- 2.1.3.3 The subject has contraindications to MRI
- Subjects must weigh <136 kg (weight limit for scanner table).
- Subjects cannot have pacemakers, cerebral aneurysm clips, shrapnel injury, or other implanted electronic devices or metal not compatible with MRI.
About this study
Official title: A Pilot, Open-label, Proof-of-Concept Study of the Use of [18F] Fluciclatide PET/CT Imaging in the Evaluation of Anti-AngiogenicTherapy in Renal Cancers
Background:
- The experimental contrast agent [18]F-Fluciclatide is being tested for cancer treatment imaging studies. It is designed to show tumors in which new blood vessels are growing. Imaging studies with [18]F-Fluciclatide may help predict how well a tumor will respond to therapy that will prevent the growth of new blood vessels. Researchers will test [18]F-Fluciclatide before beginning treatment and after the first treatment cycle. Participants may also have a third scan with [18]F-Fluciclatide between 2 and 7 days after starting treatment to look for changes in blood vessel growth early after starting therapy.
Read more
Objectives:
- To test the safety and effectiveness of [18]F-Fluciclatide in predicting cancer treatment outcomes.
Eligibility:
- Individuals at least 18 years of age who will have kidney cancer treatment to stop tumor blood vessel growth.
Design:
- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Tumor imaging studies and biopsies will be performed before starting the study.
- Participants will have two positron emission tomography (PET) and computed tomography (CT) scans. [18]F-Fluciclatide will be used for each scan. One scan will happen before the start of cancer treatment, and the second will happen after the first treatment cycle.
- Participants may also have an optional third PET/CT scan with [18]F-Fluciclatide. This scan will take place 2 to 7 days after beginning therapy.
- Depending on the location of the tumor, some participants may have an optional magnetic resonance imaging scan to look for changes in tumor blood flow and size. These scans will be done within 3 weeks of each [18]F-Fluciclatide PET/CT scan.
- The scans will be monitored with regular blood tests and vital signs.
- Participants will be followed for up to 1 year after the study to look for overall disease response to therapy.
Read the detailed description
BACKGROUND:
- Fluciclatide is a small cyclic peptide containing the RGD tri-peptide, which preferentially binds with high affinity to Alpha(v)Beta(3) integrins, which are up-regulated in and may regulate angiogenesis.
- Alpha(v)Beta(3) integrins are also expressed on certain types of tumor cells, such as renal cell cancer.
- [18F] Fluciclatide (previously known as 18F-AH111585) is a new radiopharmaceutical developed for PET imaging, which targets Alpha(v)Beta(3) receptors.
- Initial and ongoing clinical studies performed in Europe and an ongoing multicenter phase 2 proof-of-concept study (which is currently open at the NIH Clinical Center); demonstrate to date that [18F] Fluciclatide is safe and well tolerated.
PRIMARY OBJECTIVE:
- To determine tumor uptake and retention of [18F] Fluciclatide before and after 1 cycle of treatment with targeted anti-angiogenic therapy in renal cell cancer.
ELIGIBILITY:
- Adult subjects (greater than or equal to18 years old), with documented renal or metastatic renal cancer, with at least one tumor greater than or equal to1 cm in diameter outside of the liver, who are scheduled to enroll in a therapy protocol using an anti-angiogenic agent.
- The subject has a platelet count of >100,000 times 10(6)/L, hemoglobin value of >9 g/dL, prothrombin time (PT) and an activated partial thromboplastin time (aPTT) within <2 times normal limits.
- The subject has not received any targeted anti-angiogenic agents within 60 days prior to pre-treatment (baseline) [18F] Fluciclatide PET imaging.
DESIGN:
This will be a pilot, open-label, proof-of-concept study to assess the magnitude of changes in [18F] Fluciclatide PET tumor uptake following treatment with an anti-angiogenic therapy. We expect to enroll 30 evaluable patients in this single center study. When possible, the data analysis will be stratified based on the anti-angiogenic agent received. Subjects will undergo at least two [18F] Fluciclatide PET/CT imaging studies, one pre-therapy and one following completion of 1 cycle of therapy. An optional early post-therapy (2-7 days post therapy commencement) [18F] Fluciclatide PET/CT may be performed. The magnitude of [18F] Fluciclatide uptake on the preand post- treatment PET/CT studies will be evaluated to determine if there is a measureable difference in uptake. Subjects may also undergo standard of care imaging studies as part of routine tumor assessments specified in referring protocols (e.g. diagnostic CT, FDG-PET/CT, etc). Data from the subject s referring therapy protocol will be reviewed for up to one year after anti-angiogenic therapy initiation to assess for tumor response or progression and its relationship to [18F] Fluciclatide PET/CT imaging. Some patients will also undergo optional DCE-MRI scans of the target lesion and in those subjects a comparison between MR parameters and [18F]
Fluciclatide parameters will be made.
- Conditions
- Kidney Neoplasms
- Being tested
- 18F-Fluciclatide
- Keywords
- Anti-Angiogenic, Dynamic Contrast Enhanced Magnetic Resonance Imaging, PET/CT Imaging Studies
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FluciclatideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine tumor uptake and retention of [18F] Fluciclatide before and after 1 cycle of treatment with targeted anti-angiogenic therapy in renal cell cancer.
Secondary outcomes (4)
Safety of multiple IV admin. of agent.
Compare data on agent as a PD marker and SOC imaging markers of CR.
Compare DCEMRI parameters with agent PET uptake and retention.
Compare uptake and retention of agent at baseline and at the end of cycle 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study start18 Apr 2012
- Primary completion23 Apr 2014
- Study completion23 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Kidney NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Maria Liza Lindenberg, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633255
- Sponsor's protocol ID
- 120120
- Other IDs
- 12-C-0120
- Status last verified
- 23 Apr 2014
- First submitted
- 30 Jun 2012
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Egeblad M, Werb Z. New functions for the matrix metalloproteinases in cancer progression. Nat Rev Cancer. 2002 Mar;2(3):161-74. doi: 10.1038/nrc745.
PubMed 11990853Brooks PC, Clark RA, Cheresh DA. Requirement of vascular integrin alpha v beta 3 for angiogenesis. Science. 1994 Apr 22;264(5158):569-71. doi: 10.1126/science.7512751.
PubMed 7512751Line BR, Mitra A, Nan A, Ghandehari H. Targeting tumor angiogenesis: comparison of peptide and polymer-peptide conjugates. J Nucl Med. 2005 Sep;46(9):1552-60.
PubMed 16157540
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Open-label, Proof-of-Concept Study of the Use of [18F] Fluciclatide PET/CT Imaging in the Evaluation of Anti-AngiogenicTherapy in Renal Cancers
- ClinicalTrials.gov ID
- NCT01633255
- Acronym / sponsor ID
- 120120
- Conditions
- Kidney Neoplasms
- Keywords
- Anti-Angiogenic, Dynamic Contrast Enhanced Magnetic Resonance Imaging, PET/CT Imaging Studies
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 18 Apr 2012
- Primary completion
- 23 Apr 2014 (actual)
- Study completion
- 23 Apr 2014 (actual)
- First posted
- 4 Jul 2012 (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.
Background:
- The experimental contrast agent [18]F-Fluciclatide is being tested for cancer treatment imaging studies. It is designed to show tumors in which new blood vessels are growing. Imaging studies with [18]F-Fluciclatide may help predict how well a tumor will respond to therapy that will prevent the growth of new blood vessels. Researchers will test [18]F-Fluciclatide before beginning treatment and after the first treatment cycle. Participants may also have a third scan with [18]F-Fluciclatide between 2 and 7 days after starting treatment to look for changes in blood vessel growth early after starting therapy.
Objectives:
- To test the safety and effectiveness of [18]F-Fluciclatide in predicting cancer treatment outcomes.
Eligibility:
- Individuals at least 18 years of age who will have kidney cancer treatment to stop tumor blood vessel growth.
Design:
- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Tumor imaging studies and biopsies will be performed before starting the study.
- Participants will have two positron emission tomography (PET) and computed tomography (CT) scans. [18]F-Fluciclatide will be used for each scan. One scan will happen before the start of cancer treatment, and the second will happen after the first treatment cycle.
- Participants may also have an optional third PET/CT scan with [18]F-Fluciclatide. This scan will take place 2 to 7 days after beginning therapy.
- Depending on the location of the tumor, some participants may have an optional magnetic resonance imaging scan to look for changes in tumor blood flow and size. These scans will be done within 3 weeks of each [18]F-Fluciclatide PET/CT scan.
- The scans will be monitored with regular blood tests and vital signs.
- Participants will be followed for up to 1 year after the study to look for overall disease response to therapy.
Detailed description
BACKGROUND:
- Fluciclatide is a small cyclic peptide containing the RGD tri-peptide, which preferentially binds with high affinity to Alpha(v)Beta(3) integrins, which are up-regulated in and may regulate angiogenesis.
- Alpha(v)Beta(3) integrins are also expressed on certain types of tumor cells, such as renal cell cancer.
- [18F] Fluciclatide (previously known as 18F-AH111585) is a new radiopharmaceutical developed for PET imaging, which targets Alpha(v)Beta(3) receptors.
- Initial and ongoing clinical studies performed in Europe and an ongoing multicenter phase 2 proof-of-concept study (which is currently open at the NIH Clinical Center); demonstrate to date that [18F] Fluciclatide is safe and well tolerated.
PRIMARY OBJECTIVE:
- To determine tumor uptake and retention of [18F] Fluciclatide before and after 1 cycle of treatment with targeted anti-angiogenic therapy in renal cell cancer.
ELIGIBILITY:
- Adult subjects (greater than or equal to18 years old), with documented renal or metastatic renal cancer, with at least one tumor greater than or equal to1 cm in diameter outside of the liver, who are scheduled to enroll in a therapy protocol using an anti-angiogenic agent.
- The subject has a platelet count of >100,000 times 10(6)/L, hemoglobin value of >9 g/dL, prothrombin time (PT) and an activated partial thromboplastin time (aPTT) within <2 times normal limits.
- The subject has not received any targeted anti-angiogenic agents within 60 days prior to pre-treatment (baseline) [18F] Fluciclatide PET imaging.
DESIGN:
This will be a pilot, open-label, proof-of-concept study to assess the magnitude of changes in [18F] Fluciclatide PET tumor uptake following treatment with an anti-angiogenic therapy. We expect to enroll 30 evaluable patients in this single center study. When possible, the data analysis will be stratified based on the anti-angiogenic agent received. Subjects will undergo at least two [18F] Fluciclatide PET/CT imaging studies, one pre-therapy and one following completion of 1 cycle of therapy. An optional early post-therapy (2-7 days post therapy commencement) [18F] Fluciclatide PET/CT may be performed. The magnitude of [18F] Fluciclatide uptake on the preand post- treatment PET/CT studies will be evaluated to determine if there is a measureable difference in uptake. Subjects may also undergo standard of care imaging studies as part of routine tumor assessments specified in referring protocols (e.g. diagnostic CT, FDG-PET/CT, etc). Data from the subject s referring therapy protocol will be reviewed for up to one year after anti-angiogenic therapy initiation to assess for tumor response or progression and its relationship to [18F] Fluciclatide PET/CT imaging. Some patients will also undergo optional DCE-MRI scans of the target lesion and in those subjects a comparison between MR parameters and [18F]
Fluciclatide parameters will be made.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult subjects (greater than or equal to18 years old), with documented renal malignancy or metastatic renal cancer, with at least one tumor greater than or equal to1 cm in diameter (not within the liver), who are scheduled for treatment using an anti-angiogenic therapy agent
- Platelet count of >100,000 times 10(6)/L, hemoglobin value of >9 g/dL, PT and an aPTT < 2 times normal limits.
- Clinically acceptable medical history, physical examination and vital signs findings during the screening period (from <4 weeks before administration of [18F] Fluciclatide); i.e. Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2.
- The subject has had no open surgical wounds in close proximity to the target lesion(s) within 10 days prior to study entry.
- The subject has not had a needle/core biopsy of the target lesion within 10 days of PET/CT imaging.
Key exclusion criteria (14 listed)
- The subject is pregnant or nursing.
- The subject is being treated with doses of heparin or warfarin resulting in elevation of PT or aPTT >2 times normal.
- The subject has received any anti-angiogenic agent (e.g. bevacizumab, sorafenib, sunitinib) within 60 days prior to pre-treatment (baseline) [18F] Fluciclatide PE imaging. This stipulation does not apply after the baseline [18F] Fluciclatide PET imaging.
- The subject has any contraindication to any of the study procedures, products used or its constituents (e.g. severe claustrophobia unrelieved by oral anxiolytics).
- The subject is unable to lie still for 75 minutes.
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-Fluciclatide | Drug | – |
Primary outcome
To determine tumor uptake and retention of [18F] Fluciclatide before and after 1 cycle of treatment with targeted anti-angiogenic therapy in renal cell cancer.
4 secondary outcomes
Safety of multiple IV admin. of agent.
Compare data on agent as a PD marker and SOC imaging markers of CR.
Compare DCEMRI parameters with agent PET uptake and retention.
Compare uptake and retention of agent at baseline and at the end of cycle 1.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Background: PubMed 11990853Egeblad M, Werb Z. New functions for the matrix metalloproteinases in cancer progression. Nat Rev Cancer. 2002 Mar;2(3):161-74. doi: 10.1038/nrc745.
- Background: PubMed 7512751Brooks PC, Clark RA, Cheresh DA. Requirement of vascular integrin alpha v beta 3 for angiogenesis. Science. 1994 Apr 22;264(5158):569-71. doi: 10.1126/science.7512751.
- Background: PubMed 16157540Line BR, Mitra A, Nan A, Ghandehari H. Targeting tumor angiogenesis: comparison of peptide and polymer-peptide conjugates. J Nucl Med. 2005 Sep;46(9):1552-60.
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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.
Maria Liza Lindenberg, M.D. principal investigator
National Cancer Institute (NCI)
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 18F-Fluciclatide in people with Kidney Neoplasms, run by National Cancer Institute (NCI).
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 6 inclusion and 14 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: withdrawn, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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 determine tumor uptake and retention of [18F] Fluciclatide before and after 1 cycle of treatment with targeted anti-angiogenic therapy in renal cell cancer.. 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 NCT01633255, which also lists 3 linked publications.
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 17 Dec 2019.