Trial · NCT00458952

Phase 1 Study of Iobenguane (MIBG) I 131 in Patients With Malignant Pheochromocytoma/Paraganglioma

NCT00458952, Phase 1, Phase 2, Completed, Molecular Insight Pharmaceuticals, Inc.; results first posted 2016-04-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase 1 Study of Iobenguane (MIBG) I 131 in Patients With Malignant Pheochromocytoma/Paraganglioma. Trials, record NCT00458952. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00458952

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Phase 1 Study of Iobenguane (MIBG) I 131 in Patients With Malignant Pheochromocytoma/Paraganglioma
NCT number: NCT00458952
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 24 participants, actual
Lead sponsor: Molecular Insight Pharmaceuticals, Inc.
Conditions: Pheochromocytoma, Paraganglioma
Interventions: Ultratrace Iobenguane (MIBG) I 131
First posted: 2007-04-11
Last updated: 2016-07-13
Results first posted: 2016-04-20

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	MTD of Ultratrace Iobenguane I 131	6 weeks post therapy dose	Although no primary efficacy endpoint was defined for this study, the MTD of Ultratrace iobenguane I 131 in patients with malignant pheochromocytoma/paraganglioma (a safety rather than an efficacy parameter) is the primary objective.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	MTD of Ultratrace Iobenguane I 131	6 weeks post therapy dose	24 patients with confirmed pheochromocytoma/paraganglioma were recruited for participation in this trial. Of the 24 consenting patients, 21 patients were administered Ultratrace iobenguane I 131. Three patients did not meet all the inclusion and exclusion criteria, and were not allowed into the study.	mCi/kg	NUMBER

Source ClinicalTrials.gov

Results by group1

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
MTD of Ultratrace Iobenguane I 131	Ultratrace Iobenguane I 131		8		mCi/kg

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	=< 500 mCi Ultratrace Iobenguane I 131	7
Overall Study	STARTED	>500 mCi	14
Overall Study	COMPLETED	=< 500 mCi Ultratrace Iobenguane I 131	5
Overall Study	COMPLETED	>500 mCi	9
Overall Study	NOT COMPLETED	=< 500 mCi Ultratrace Iobenguane I 131	2
Overall Study	NOT COMPLETED	>500 mCi	5

Source ClinicalTrials.gov

Adverse events43

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Fatigue	General disorders	Ultratrace Iobenguane I 131	14	21
other	Asthenia	General disorders	Ultratrace Iobenguane I 131	4	21
other	Injection site irritation	General disorders	Ultratrace Iobenguane I 131	3	21
other	Edema peripheral	General disorders	Ultratrace Iobenguane I 131	3	21
other	Pyrexia	General disorders	Ultratrace Iobenguane I 131	3	21
other	Leukopenia	Blood and lymphatic system disorders	Ultratrace Iobenguane I 131	10	21
other	Neutropenia	Blood and lymphatic system disorders	Ultratrace Iobenguane I 131	9	21
other	Thrombocytopenia	Blood and lymphatic system disorders	Ultratrace Iobenguane I 131	10	21
other	Anemia	Blood and lymphatic system disorders	Ultratrace Iobenguane I 131	9	21
other	Back pain	Musculoskeletal and connective tissue disorders	Ultratrace Iobenguane I 131	5	21

1 to 10 of 43Source ClinicalTrials.gov

See all 43 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ultratrace Iobenguane I 131
Total, other adverse events	Ultratrace Iobenguane I 131	20	21
Total, serious adverse events	Ultratrace Iobenguane I 131	15	21

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
29099942	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00458952

GET https://conductscience.org/api/trials/v1/NCT00458952/events?page=2

API reference For AI assistants