SchwannomasPhase 1NCT03542773
Targeted Imaging of Glutamate Carboxypeptidase II With DCFPyL-PET
A Phase 1 study testing 18F-DCFPyL Injection in people with Schwannomas and Malignant Tumors, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
To use 18F-DCFPyL imaging agent and PET/CT to detect none prostate cancer solid malignancies and schwannoma tumors. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Schwannomas, Malignant Tumors
- What is being tested?
- 18F-DCFPyL Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2015to 1 May 2022
- Phase
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Greater than or equal to 18 years of age
- Biopsy-proven cancer or Schwannoma diagnosis
- No contraindications to PET scanning to include pregnancy, etc. For females of childbearing potential, negative serum pregnancy test obtained within a 10-day period prior to PET study
- Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures.
Who cannot join
- Administered a radioisotope within 5 physical half-lives prior to PET imaging
- In female subjects pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
To use 18F-DCFPyL imaging agent and PET/CT to detect none prostate cancer solid malignancies and schwannoma tumors.
Read the detailed description
The purpose of this protocol is to extend our existing patient base from those with prostate cancer to those with any solid malignancy - as well as patients with schwannoma, a non-malignant solid tumor that also over-expresses GCP II. Using our first generation imaging agent, [18F]DCFBC, we have shown that we could detect GCP II in tissue specimens of patients with a variety of cancers, and vestibular schwannoma. We have also shown that GCP II may not only be present in the neovasculature of solid (non-prostate) tumors, but also reside within the tumor epithelium itself. We have shown that to be the case for melanoma, in particular. Our goal is to leverage the broad utility of our GCP II targeted imaging agents for managing other cancers. In addition to schwannoma, the cancers we intend to target include but will not be restricted to: head and neck cancer, salivary gland tumors, renal cell carcinoma, transitional cell carcinoma, colorectal cancer, gastric cancer, neuroendocrine cancer, glioblastoma, melanoma, pancreatic cancer, non-small cell lung cancer, soft tissue sarcoma, breast cancer, endometrial cancer, ovarian cancer, lymphoma and multiple myeloma.
- Conditions
- Schwannomas, Malignant Tumors
- Being tested
- 18F-DCFPyL Injection
- Medical subject headings
- Neurilemmoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-DCFPyL InjectionDrug
Also called PyL
18F-DCFPyL with whole body PET/CT scan
| Study group | Role | What they receive |
|---|---|---|
| 18F-DCFPyL | Experimental | A bolus of less than or equal to 9 mCi (331 MBq) of IV injection of 18F-DCFPyL Receives: Drug: 18F-DCFPyL Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine feasibility of using 18F-DCFPyL to detect cancer
The primary objective of this project is to test the feasibility of 18F-DCFPyL to detect cancer. The visual assessment of suspected tumor will be considered positive if there is sustained radiotracer activity over expected soft tissue or blood pool physiologic activity levels and recorded as mild (above blood pool), moderate (above blood pool, but less than liver), or intense (at or above the liver). Feasibility will be determined based on number of positively recognized regions of interest.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start6 Feb 2015
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchwannomasStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Steven Rowe, M.D., Ph.D, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542773
- Sponsor's protocol ID
- J14124
- Other IDs
- IRB00046315, P50CA103175
- Status last verified
- Jan 2023
- First submitted
- 13 Jan 2015
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Imaging of Glutamate Carboxypeptidase II With DCFPyL-PET
- ClinicalTrials.gov ID
- NCT03542773
- Acronym / sponsor ID
- J14124
- Conditions
- Schwannomas, Malignant Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 Feb 2015 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 31 May 2018 (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.
To use 18F-DCFPyL imaging agent and PET/CT to detect none prostate cancer solid malignancies and schwannoma tumors.
Detailed description
The purpose of this protocol is to extend our existing patient base from those with prostate cancer to those with any solid malignancy - as well as patients with schwannoma, a non-malignant solid tumor that also over-expresses GCP II. Using our first generation imaging agent, [18F]DCFBC, we have shown that we could detect GCP II in tissue specimens of patients with a variety of cancers, and vestibular schwannoma. We have also shown that GCP II may not only be present in the neovasculature of solid (non-prostate) tumors, but also reside within the tumor epithelium itself. We have shown that to be the case for melanoma, in particular. Our goal is to leverage the broad utility of our GCP II targeted imaging agents for managing other cancers. In addition to schwannoma, the cancers we intend to target include but will not be restricted to: head and neck cancer, salivary gland tumors, renal cell carcinoma, transitional cell carcinoma, colorectal cancer, gastric cancer, neuroendocrine cancer, glioblastoma, melanoma, pancreatic cancer, non-small cell lung cancer, soft tissue sarcoma, breast cancer, endometrial cancer, ovarian cancer, lymphoma and multiple myeloma.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-DCFPyL | Experimental | Drug: 18F-DCFPyL InjectionA bolus of less than or equal to 9 mCi (331 MBq) of IV injection of 18F-DCFPyL |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Greater than or equal to 18 years of age
- Biopsy-proven cancer or Schwannoma diagnosis
- No contraindications to PET scanning to include pregnancy, etc. For females of childbearing potential, negative serum pregnancy test obtained within a 10-day period prior to PET study
- Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures.
Key exclusion criteria (2 listed)
- Administered a radioisotope within 5 physical half-lives prior to PET imaging
- In female subjects pregnancy.
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-DCFPyL InjectionAlso: PyL18F-DCFPyL with whole body PET/CT scan | Drug | 18F-DCFPyL |
Primary outcome
Determine feasibility of using 18F-DCFPyL to detect cancer
Time frame: 24 months
The primary objective of this project is to test the feasibility of 18F-DCFPyL to detect cancer. The visual assessment of suspected tumor will be considered positive if there is sustained radiotracer activity over expected soft tissue or blood pool physiologic activity levels and recorded as mild (above blood pool), moderate (above blood pool, but less than liver), or intense (at or above the liver). Feasibility will be determined based on number of positively recognized regions of interest.
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 11 Jan 2023.
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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.
Steven Rowe, M.D., Ph.D principal investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 18F-DCFPyL Injection in people with Schwannomas and Malignant Tumors, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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 4 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 11 Jan 2023. 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?
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.
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?
Determine feasibility of using 18F-DCFPyL to detect cancer (time frame: 24 months). 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 11 Jan 2023.