Central Nervous System TumorsPhase 1NCT00477503
Nuclear Imaging of Human CSF Flow Using Ga-67 Citrate and In-111 DTPA
A Phase 1 study testing Gallium-67 Citrate (Ga-67) and In-111 DTPA (In-111 pentetate) in people with Central Nervous System Tumors and Brain Tumors, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objective will be to evaluate the use of Ga-67 citrate as an alternative radiopharmaceutical for CSF imaging. Secondary Objective will be to evaluate the biodistribution, pharmacokinetics and radiation dosimetry of In 111 DTPA and gallium-67 after intrathecal injection during remission of leptomeningeal… Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Central Nervous System Tumors, Brain Tumors
- What is being tested?
- Gallium-67 Citrate (Ga-67) and In-111 DTPA (In-111 pentetate)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Jul 2009
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants must have provided informed consent.
- Participants must be 2 years of age or older.
- Participants must have known history of LM as established by CSF cytology.
- Participants must have an Ommaya reservoir implanted at least 2 days before the study.
- Participants with ventriculoperitoneal shunts are eligible as long as the shunt is not in the "open" position during the imaging session.
- Participants with adequate renal and hepatic function. Creatinine =< 1.4 mg/dL Bilirubin =< 2.0 mg/dL BUN =< 30 SGOT (AST), alkaline phosphatase =<3 x upper norm (Institutional norm of SGOT = 7-56 mIU/ml and alkaline phosphatase = 38-126 IU/L.).
- Urine analysis within normal limits.
- Women of child bearing potential (WOCBP) must have a negative serum B-HCG pregnancy test within 7 days of treatment. WOCBP is defined as not post-menopausal for 12 months or no previous surgical sterilization.
Who cannot join
- Participants on concurrent external beam radiation therapy to the brain or spine during the planned nuclear imaging sessions.
- Participants on concurrent intrathecal chemotherapy during imaging sessions.
- Participants with Karnofsky Performance Scale <50 or Zubrod Performance Scale >2.
- Participants with known or suspected renal or hepatic disease that have not been adequately treated to achieve normalized liver function tests or renal function tests to the above eligible criteria.
- Participants with known history of claustrophobia, as established by medical records or claimed by patient.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase 1 Study Nuclear Imaging of Human CSF Flow Using Ga-67 Citrate and In-111 DTPA
- Primary Objective will be to evaluate the use of Ga-67 citrate as an alternative radiopharmaceutical for CSF imaging.
- Secondary Objective will be to evaluate the biodistribution, pharmacokinetics and radiation dosimetry of In 111 DTPA and gallium-67 after intrathecal injection during remission of leptomeningeal metastasis (LM) and during LM occurrence, remission and recurrence.
Read the detailed description
In-111 DTPA is a radioactive dye that is standardly used to check the flow of CSF. Ga-67 citrate has been used to detect inflammation and tumors in other parts of the body, and researchers want to learn if it is also able to detect tumors in the brain and spinal cord.
Before you can be enrolled in this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Blood (about 1-2 tablespoons) will be drawn for routine tests. This routine blood draw will include a pregnancy test for women who are able to have children. To be eligible to take part in this study, the pregnancy test must be negative.
If you are found to be eligible to take part in this study, you will be assigned to 1 of 3 groups. The group you are assigned to will depend on whether tumor cells were found in the CSF during your last spinal fluid exam. If you were found to have cancer cells in the CSF and you have had no earlier treatment for this type of disease, the first 5 participants will be assigned to Group A and will be given Ga-67 citrate injection alone, in the baseline study. The next 5 participants who have cancer cells in the CSF and have had no earlier treatment will be assigned to Group B. Group B will have Ga-67 and In 111 DTPA injection in the baseline study. Otherwise, if the tumors in the CSF have been treated and are now cleared from the CSF, you will be assigned to Group C and will receive standard follow-up care.
At the beginning of the study, you will have an imaging session. This first imaging session is called the "baseline" session. For the imaging, you will lie on a gamma camera table. Depending on which group you are in, one or both of the radioactive dyes will be injected into your CSF through the Ommaya reservoir. If you are in Group B or C, both In-111 DTPA and Ga-67 citrate will be injected over about 2-4 minutes, total. If you are in Group A, Ga-67 citrate alone will be injected over about 2 minutes.
For participants who are 2-17 years old, the doses of In-111 DTPA and Ga-67 citrate will be adjusted to the surface area of your body (a measurement of your body size).
During the hour immediately following the injections, your head, neck, and back areas will be imaged (scanned) in order to see how the CSF flows. After that, you will have scans of your entire body performed in order to see how quickly the radioactive dyes leave from different parts of your body. These whole-body scans will each last 20 minutes. These scans (1 each time) will occur at 1-2, 3-4, 6-8, 22-24, 28-32, 48, and 72 hours after the injections. You will have blood samples collected before injection and during each imaging session in order to measure how much radiation is absorbed by different parts of your brain, spine, and other organs. These blood samples (less than ¼ teaspoon each time) will be drawn during each of the whole-body scans.
If you are in Group A or B, you will receive standard follow-up care for up to 52 weeks after the baseline imaging session. This is in order to check the status of the disease. If the cancer goes into remission (no tumor cells are found in CSF) at any time during the 52 weeks, you will have a follow-up imaging session. The follow-up imaging session will include the same procedures, and In-111 DTPA and/or Ga-67 citrate injections as the baseline imaging session.
If you are in Group C, you will receive standard follow-up care for up to 52 weeks after the baseline imaging session. If the cancer reappears at any time during the 52 weeks, you will have a follow-up imaging session. The follow-up imaging session will include the same procedures, and In-111 DTPA and Ga-67 citrate injections as the baseline imaging session.
Whether you are in Group A, B or C, after your last follow-up imaging session, your participation in this study will be over. If your cancer clears from the spinal fluid, the records from your routine visit to the neuro-oncology clinic will be reviewed to follow your progress until 30 days after the radioisotope injection for your last imaging session. Researchers will review your medical records for potential side effects. If you do not have a clinical visit within a week from that 30th day, the study chair will contact you by phone concerning these matters.
This is an investigational study. In-111 DTPA is commercially available and FDA approved for injection into the CSF. Although Ga-67 citrate is FDA approved for injection into a vein, it is not FDA approved for injection into the CSF. It is commercially available, but injecting it into the CSF has only been authorized for use in research. Up to 20 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Central Nervous System Tumors, Brain Tumors
- Being tested
- Gallium-67 Citrate (Ga-67), In-111 DTPA (In-111 pentetate)
- Keywords
- Central Nervous System Tumors, Brain Tumors, Leptomeningeal Metastasis, Cerebral Spinal Fluid, Human CSF Flow, Nuclear Imaging, Gallium-67 Citrate, In-111 DTPA
- Medical subject headings
- Central Nervous System Neoplasms, Brain Neoplasms, Meningeal Carcinomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gallium-67 Citrate (Ga-67)Drug
Group A: Ga-67 citrate injection alone, in the baseline study.
Group B: Ga-67 and In 111 DTPA injection in the baseline study.
Group C: Standard of care with Ga-67 and In 111 DTPA injection in baseline study.
In-111 DTPA (In-111 pentetate)Drug
Also called DTPA
Group B: Ga-67 and In 111 DTPA injection in the baseline study.
Group C: Standard of care with Ga-67 and In 111 DTPA injection in baseline study.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Ga-67 citrate injection alone for individuals with cancer cells in cerebral spinal fluid (CSF), no earlier treatment for disease. Receives: Drug: Gallium-67 Citrate (Ga-67) |
| Group B | Active comparator | Ga-67 + In 111 DTPA injection for individuals who have cancer cells in CSF, no earlier treatment for disease. Receives: Drug: Gallium-67 Citrate (Ga-67); Drug: In-111 DTPA (In-111 pentetate) |
| Group C | Active comparator | Individuals with tumors in the CSF that have been treated and are now cleared from the CSF, receive standard follow-up care (baseline injection of Ga-67 citrate and In-111 DTPA). Receives: Drug: Gallium-67 Citrate (Ga-67); Drug: In-111 DTPA (In-111 pentetate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare Ga-67 citrate with a standard radioactive dye in order to learn if Ga-67 citrate can help doctors to check the flow of CSF for any blockage.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2007 (estimated)
- Study startMay 2007
- Primary completionJul 2009
- Study completionJul 2009
Why it stopped: One participant enrolled, study terminated .
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Franklin C Wong, M.D., Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00477503
- Sponsor's protocol ID
- 2006-0623
- Status last verified
- Jul 2012
- First submitted
- 21 May 2007
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study Nuclear Imaging of Human CSF Flow Using Ga-67 Citrate and In-111 DTPA
- ClinicalTrials.gov ID
- NCT00477503
- Acronym / sponsor ID
- 2006-0623
- Conditions
- Central Nervous System Tumors, Brain Tumors
- Keywords
- Central Nervous System Tumors, Brain Tumors, Leptomeningeal Metastasis, Cerebral Spinal Fluid, Human CSF Flow, Nuclear Imaging, Gallium-67 Citrate, In-111 DTPA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: One participant enrolled, study terminated .
- Enrolment
- 1 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 23 May 2007 (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.
- Primary Objective will be to evaluate the use of Ga-67 citrate as an alternative radiopharmaceutical for CSF imaging.
- Secondary Objective will be to evaluate the biodistribution, pharmacokinetics and radiation dosimetry of In 111 DTPA and gallium-67 after intrathecal injection during remission of leptomeningeal metastasis (LM) and during LM occurrence, remission and recurrence.
Detailed description
In-111 DTPA is a radioactive dye that is standardly used to check the flow of CSF. Ga-67 citrate has been used to detect inflammation and tumors in other parts of the body, and researchers want to learn if it is also able to detect tumors in the brain and spinal cord.
Before you can be enrolled in this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Blood (about 1-2 tablespoons) will be drawn for routine tests. This routine blood draw will include a pregnancy test for women who are able to have children. To be eligible to take part in this study, the pregnancy test must be negative.
If you are found to be eligible to take part in this study, you will be assigned to 1 of 3 groups. The group you are assigned to will depend on whether tumor cells were found in the CSF during your last spinal fluid exam. If you were found to have cancer cells in the CSF and you have had no earlier treatment for this type of disease, the first 5 participants will be assigned to Group A and will be given Ga-67 citrate injection alone, in the baseline study. The next 5 participants who have cancer cells in the CSF and have had no earlier treatment will be assigned to Group B. Group B will have Ga-67 and In 111 DTPA injection in the baseline study. Otherwise, if the tumors in the CSF have been treated and are now cleared from the CSF, you will be assigned to Group C and will receive standard follow-up care.
At the beginning of the study, you will have an imaging session. This first imaging session is called the "baseline" session. For the imaging, you will lie on a gamma camera table. Depending on which group you are in, one or both of the radioactive dyes will be injected into your CSF through the Ommaya reservoir. If you are in Group B or C, both In-111 DTPA and Ga-67 citrate will be injected over about 2-4 minutes, total. If you are in Group A, Ga-67 citrate alone will be injected over about 2 minutes.
For participants who are 2-17 years old, the doses of In-111 DTPA and Ga-67 citrate will be adjusted to the surface area of your body (a measurement of your body size).
During the hour immediately following the injections, your head, neck, and back areas will be imaged (scanned) in order to see how the CSF flows. After that, you will have scans of your entire body performed in order to see how quickly the radioactive dyes leave from different parts of your body. These whole-body scans will each last 20 minutes. These scans (1 each time) will occur at 1-2, 3-4, 6-8, 22-24, 28-32, 48, and 72 hours after the injections. You will have blood samples collected before injection and during each imaging session in order to measure how much radiation is absorbed by different parts of your brain, spine, and other organs. These blood samples (less than ¼ teaspoon each time) will be drawn during each of the whole-body scans.
If you are in Group A or B, you will receive standard follow-up care for up to 52 weeks after the baseline imaging session. This is in order to check the status of the disease. If the cancer goes into remission (no tumor cells are found in CSF) at any time during the 52 weeks, you will have a follow-up imaging session. The follow-up imaging session will include the same procedures, and In-111 DTPA and/or Ga-67 citrate injections as the baseline imaging session.
If you are in Group C, you will receive standard follow-up care for up to 52 weeks after the baseline imaging session. If the cancer reappears at any time during the 52 weeks, you will have a follow-up imaging session. The follow-up imaging session will include the same procedures, and In-111 DTPA and Ga-67 citrate injections as the baseline imaging session.
Whether you are in Group A, B or C, after your last follow-up imaging session, your participation in this study will be over. If your cancer clears from the spinal fluid, the records from your routine visit to the neuro-oncology clinic will be reviewed to follow your progress until 30 days after the radioisotope injection for your last imaging session. Researchers will review your medical records for potential side effects. If you do not have a clinical visit within a week from that 30th day, the study chair will contact you by phone concerning these matters.
This is an investigational study. In-111 DTPA is commercially available and FDA approved for injection into the CSF. Although Ga-67 citrate is FDA approved for injection into a vein, it is not FDA approved for injection into the CSF. It is commercially available, but injecting it into the CSF has only been authorized for use in research. Up to 20 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Gallium-67 Citrate (Ga-67)Ga-67 citrate injection alone for individuals with cancer cells in cerebral spinal fluid (CSF), no earlier treatment for disease. |
| Group B | Active comparator | Drug: Gallium-67 Citrate (Ga-67), Drug: In-111 DTPA (In-111 pentetate)Ga-67 + In 111 DTPA injection for individuals who have cancer cells in CSF, no earlier treatment for disease. |
| Group C | Active comparator | Drug: Gallium-67 Citrate (Ga-67), Drug: In-111 DTPA (In-111 pentetate)Individuals with tumors in the CSF that have been treated and are now cleared from the CSF, receive standard follow-up care (baseline injection of Ga-67 citrate and In-111 DTPA). |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Participants must have provided informed consent.
- Participants must be 2 years of age or older.
- Participants must have known history of LM as established by CSF cytology.
- Participants must have an Ommaya reservoir implanted at least 2 days before the study.
- Participants with ventriculoperitoneal shunts are eligible as long as the shunt is not in the "open" position during the imaging session.
Key exclusion criteria (5 listed)
- Participants on concurrent external beam radiation therapy to the brain or spine during the planned nuclear imaging sessions.
- Participants on concurrent intrathecal chemotherapy during imaging sessions.
- Participants with Karnofsky Performance Scale <50 or Zubrod Performance Scale >2.
- Participants with known or suspected renal or hepatic disease that have not been adequately treated to achieve normalized liver function tests or renal function tests to the above eligible criteria.
- Participants with known history of claustrophobia, as established by medical records or claimed by patient.
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 |
|---|---|---|
| Gallium-67 Citrate (Ga-67)Group A: Ga-67 citrate injection alone, in the baseline study. Group B: Ga-67 and In 111 DTPA injection in the baseline study. Group C: Standard of care with Ga-67 and In 111 DTPA injection in baseline study. | Drug | Group A, Group B, Group C |
| In-111 DTPA (In-111 pentetate)Also: DTPAGroup B: Ga-67 and In 111 DTPA injection in the baseline study. Group C: Standard of care with Ga-67 and In 111 DTPA injection in baseline study. | Drug | Group B, Group C |
Primary outcome
To compare Ga-67 citrate with a standard radioactive dye in order to learn if Ga-67 citrate can help doctors to check the flow of CSF for any blockage.
Time frame: 3 years
Results and safety
The study was stopped early (reason given: One participant enrolled, study terminated .). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2012.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Franklin C Wong, M.D. principal investigator
M.D. Anderson Cancer Center
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 Gallium-67 Citrate (Ga-67) and In-111 DTPA (In-111 pentetate) in people with Central Nervous System Tumors and Brain Tumors, run by M.D. Anderson Cancer Center 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 8 inclusion and 5 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: stopped early, as of the sponsor's last update on 1 Aug 2012. 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 was stopped early (reason given: One participant enrolled, study terminated .). Results are not available in the source record.
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 compare Ga-67 citrate with a standard radioactive dye in order to learn if Ga-67 citrate can help doctors to check the flow of CSF for any blockage. (time frame: 3 years). 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 1 Aug 2012.