Clinical trial · Interventional
Combination Targeted Radiotherapy in Neuroendocrine Tumors
NCT01099228CI-TRIAL-00023181completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary aim of this project is to determine, what fraction of individuals with neuroendocrine tumors would show substantially improved tumor dosimetry with combined agent therapy compared to "best" single agent therapy and determine the magnitude of the potential tumor radiation dose increase.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 131-I MIBG and 111-In pentetreotide | Other | — | UNRESOLVED |
| 131-I MIBG and In-111 DOTATATE | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 131-I MIBG and 111I-n pentetreotide
- description
- 131-I MIBG and 111I-n pentetreotide
- interventionNames
- Other: 131-I MIBG and 111-In pentetreotide
- type
- ACTIVE_COMPARATOR
- label
- 131-I MIBG and In-111 DOTATATE
- description
- 131-I MIBG and In-111 DOTATATE
- interventionNames
- Other: 131-I MIBG and In-111 DOTATATE
Primary outcomes (1)
- measure
- Dosimetry Results
- timeFrame
- 1 week after scan
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects with biopsy-proven metastatic (soft tissue) neuroendocrine tumors. * Subjects with a Southwest Oncology Group (SWOG) performance score of 0-2 and an expected median survival of at least 6 months. * The subject is able and willing to comply with study procedures and a signed and dated informed consent is obtained. * Subjects must be \>18 years of age Exclusion Criteria: * Subjects who use medications that are known to interfere with MIBG uptake and is unable to discontinue for medical reasons. * Prior chemotherapy, radiotherapy or any investigational drugs within 60 days prior admission into this study. Patients must have recovered from all therapy-related toxicities * Renal insufficiency with a serum creatinine 2 X ULN * Subjects unable to lie still for the imaging studies. * Subjects who because of their weight and body distribution do not fit into the imaging machine. * Subjects receiving Sandostatin LAR \< 21 days prior to dosing or Sandostatin Immediate Release (IR) \< 24 hours prior to dosing. * Female patients who are pregnant or breast feeding. Women of childbearing potential must have a negative serum/urine pregnancy test within 48 hours prior to administration of study treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.