## Protocol Section
### Identification Module
**NCT ID:** NCT02174679

**Brief Title:** 68Ga DOTATATE PET/CT in Neuroendocrine Tumors (Expanded Access)

**Official Title:** 68Ga-DOTATATE Imaging in Neuroendocrine Tumors

#### Organization Study ID Info
**ID:** DOTATATE12-001920EA
#### Organization
**Class:** OTHER
**Full Name:** Jonsson Comprehensive Cancer Center
#### Secondary ID Infos
**Domain:** CTRP
**ID:** NCI-2016-01796
**Type:** OTHER
**Domain:** Jonsson Comprehensive Cancer Center
**ID:** JCCCID324
**Type:** OTHER
### Status Module
#### Last Update Post Date
**Date:** 2020-07-27

**Type:** ACTUAL

**Last Update Submit Date:** 2020-07-23

**Overall Status:** NO_LONGER_AVAILABLE

**Status Verified Date:** 2019-05

#### Study First Post Date
**Date:** 2014-06-25
**Type:** ESTIMATED
**Study First Submit Date:** 2014-06-20
**Study First Submit QC Date:** 2014-06-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Jonsson Comprehensive Cancer Center

#### Responsible Party

**Type:** SPONSOR

### Description Module

**Brief Summary:** To evaluate 68Ga-DOTATATE PET/CT for staging of patients with carcinoid, neuroendocrine tumors, medullary thyroid cancer and other cancers expressing somatostatin receptors.

**Detailed Description:** This is an expanded access study with a total of 300 participants with NET and suspected SSTR positive tumors. Eligible participants will undergo baseline assessments at enrollment. Study participants will receive 68Ga-DOTATATE and will undergo a PET/CT imaging study. All patients referred by Oncologists will be screened by a UCLA Nuclear Medicine physician and then accepted for scanning if clinically appropriate.

### Conditions Module

**Conditions:**

- Carcinoid Cancer

- Neuroendocrine Tumors

- Medullary Thyroid Cancer

- Cancers Expressing Somatostatin Receptors

### Design Module

**Study Type:** EXPANDED_ACCESS

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** Patients with somatostatin receptor positive tumors will be evaluated with 68Ga-DOTATATE PET/CT.

**Name:** 68Ga DOTATATE

**Other Names:**

- 68Ga DOTATATE PET/CT Scan

**Type:** DRUG

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Older than 18 years the time of radiotracer administration
* Provides written informed consent
* Known diagnosis of NET or suspected SSTR positive tumors Women of childbearing age must have a negative pregnancy test at screening/baseline
* Able to remain still for duration of each imaging procedure (about 30 minutes)

Exclusion Criteria:

* Less than 18 years-old at the time of radiotracer administration
* Pregnant or nursing
* Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
* Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Los Angeles

**Country:** United States

**Facility:** UCLA Hospital

**State:** California

**Zip:** 90095

#### Overall Officials

**Official 1:**

**Affiliation:** University of California, Los Angeles

**Name:** Johannes Czernin, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Modlin IM, Kidd M, Hinoue T, Lye KD, Murren J, Argiris A. Molecular strategies and 111in-labelled somatostatin analogues in defining the management of neuroendocrine tumour disease: a new paradigm for surgical management. Surgeon. 2003 Jun;1(3):137-43. doi: 10.1016/s1479-666x(03)80092-6.

**PMID:** 15570748

**Citation:** Modlin IM, Latich I, Zikusoka M, Kidd M, Eick G, Chan AK. Gastrointestinal carcinoids: the evolution of diagnostic strategies. J Clin Gastroenterol. 2006 Aug;40(7):572-82. doi: 10.1097/00004836-200608000-00003.

**PMID:** 16917396

**Citation:** Graham MM, Menda Y. Radiopeptide imaging and therapy in the United States. J Nucl Med. 2011 Dec;52 Suppl 2:56S-63S. doi: 10.2967/jnumed.110.085746.

**PMID:** 22144556

**Citation:** Virgolini I, Ambrosini V, Bomanji JB, Baum RP, Fanti S, Gabriel M, Papathanasiou ND, Pepe G, Oyen W, De Cristoforo C, Chiti A. Procedure guidelines for PET/CT tumour imaging with 68Ga-DOTA-conjugated peptides: 68Ga-DOTA-TOC, 68Ga-DOTA-NOC, 68Ga-DOTA-TATE. Eur J Nucl Med Mol Imaging. 2010 Oct;37(10):2004-10. doi: 10.1007/s00259-010-1512-3.

**PMID:** 20596866

**Citation:** Buchmann I, Henze M, Engelbrecht S, Eisenhut M, Runz A, Schafer M, Schilling T, Haufe S, Herrmann T, Haberkorn U. Comparison of 68Ga-DOTATOC PET and 111In-DTPAOC (Octreoscan) SPECT in patients with neuroendocrine tumours. Eur J Nucl Med Mol Imaging. 2007 Oct;34(10):1617-26. doi: 10.1007/s00259-007-0450-1. Epub 2007 May 23.

**PMID:** 17520251

**Citation:** Calais J, Czernin J, Eiber M, Fendler WP, Gartmann J, Heaney AP, Hendifar AE, Pisegna JR, Hecht JR, Wolin EM, Slavik R, Gupta P, Quon A, Schiepers C, Allen-Auerbach MS, Herrmann K. Most of the Intended Management Changes After 68Ga-DOTATATE PET/CT Are Implemented. J Nucl Med. 2017 Nov;58(11):1793-1796. doi: 10.2967/jnumed.117.192450. Epub 2017 May 4.

**PMID:** 28473600

#### See Also Links

**Label:** UCLA Ahmanson Translational Imaging Division

**URL:** http://pet.ucla.edu

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009369

- Term: Neoplasms

- ID: D000017599

- Term: Neuroectodermal Tumors

- ID: D000009373

- Term: Neoplasms, Germ Cell and Embryonal

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009380

- Term: Neoplasms, Nerve Tissue

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M20495

- Name: Neuroendocrine Tumors

- Relevance: HIGH

- As Found: Neuroendocrine Tumors

- ID: M16718

- Name: Thyroid Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16723

- Name: Thyroid Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M5533

- Name: Carcinoid Tumor

- Relevance: LOW

- As Found: Unknown

- ID: M19845

- Name: Neuroectodermal Tumors

- Relevance: LOW

- As Found: Unknown

- ID: M20388

- Name: Neuroectodermal Tumors, Primitive

- Relevance: LOW

- As Found: Unknown

- ID: M12318

- Name: Neoplasms, Germ Cell and Embryonal

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M12325

- Name: Neoplasms, Nerve Tissue

- Relevance: LOW

- As Found: Unknown

- ID: T4091

- Name: Neuroendocrine Tumor

- Relevance: HIGH

- As Found: Neuroendocrine Tumors

- ID: T5651

- Name: Thyroid Cancer, Medullary

- Relevance: HIGH

- As Found: Medullary Thyroid Cancer

- ID: T948

- Name: Carcinoid Tumor

- Relevance: LOW

- As Found: Unknown

- ID: T4092

- Name: Neuroepithelioma

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000018358

- Term: Neuroendocrine Tumors

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M15806

- Name: Somatostatin

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
