Clinical trial · Interventional
Nuclear Imaging of Human CSF Flow Using Ga-67 Citrate and In-111 DTPA
Phase 1 Study Nuclear Imaging of Human CSF Flow Using Ga-67 Citrate and In-111 DTPA
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): One participant enrolled, study terminated .
Summary
Brief summary (as posted)
* 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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumors | Brain Neoplasm | ALIAS | 0.90 |
| Central Nervous System Tumors | Central Nervous System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gallium-67 Citrate (Ga-67) | Drug | — | UNRESOLVED |
| In-111 DTPA (In-111 pentetate) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Group A
- description
- Ga-67 citrate injection alone for individuals with cancer cells in cerebral spinal fluid (CSF), no earlier treatment for disease.
- interventionNames
- Drug: Gallium-67 Citrate (Ga-67)
- type
- ACTIVE_COMPARATOR
- label
- Group B
- description
- Ga-67 + In 111 DTPA injection for individuals who have cancer cells in CSF, no earlier treatment for disease.
- interventionNames
- Drug: Gallium-67 Citrate (Ga-67)
- Drug: In-111 DTPA (In-111 pentetate)
- type
- ACTIVE_COMPARATOR
- label
- Group C
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available