Trial Outcomes & Findings for Radioactive Iodine Implants for Pan-invasive Pituitary Macroadenomas (NCT NCT01444209)

NCT ID: NCT01444209

Last Updated: 2021-11-30

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

12 months

Results posted on

2021-11-30

Participant Flow

Participant milestones

Participant milestones
Measure	Radiation Therapy Interstitial Radioactive Iodine Implants Iodine Implants: Interstitial Radioactive Iodine Implants
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Radioactive Iodine Implants for Pan-invasive Pituitary Macroadenomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Radiation Therapy n=2 Participants Interstitial Radioactive Iodine Implants Iodine Implants: Interstitial Radioactive Iodine Implants
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	2 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	2 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	2 participants n=93 Participants

PRIMARY outcome

Timeframe: 12 months

Population: No data collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Population: Data were not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Population: No data collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Population: No data collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Population: No data collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Population: No data collected

Outcome measures

Outcome data not reported

Adverse Events

Radiation Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Robert Timmerman

University of Texas Southwestern Medical Center

Phone: 214/645-7637

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place