Is NCT06784752 recruiting in Denver, CO?

Yes, NCT06784752 is currently recruiting participants at its Denver, CO location. This neuroendocrine tumors clinical trial is actively enrolling qualified participants.

How do I join the neuroendocrine tumors clinical trial in Denver?

To join this clinical trial in Denver, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Denver clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Neuroendocrine Tumors Clinical Trial in Denver, CO

About This Neuroendocrine Tumors Study in Denver

The purpose of the current study is to evaluate the efficacy and safety of \[177Lu\]Lu-DOTA-TATE plus octreotide long-acting release (LAR) versus octreotide LAR alone in newly diagnosed patients with somatostatin receptor positive (SSTR+), well differentiated Grade1 and Grade 2 (G1 and G2) (Ki-67 \<10%) advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) with high disease burden

Sponsor: Novartis Pharmaceuticals

Who Can Participate

Inclusion Criteria

Presence of metastasized or locally advanced, unresectable (curative intent), histologically proven, well differentiated Grade 1 or Grade 2 (Ki-67 \<10%) gastroenteropancreatic neuroendocrine tumor (GEP-NET) diagnosed within 6 months prior to screening.

Participants with high disease burden in the Investigator's opinion. Following criteria should be used as the guiding principle for determining high disease burden:

Primary tumor or a metastatic lesion \> 4 cm

More than one tumor or metastatic lesions measuring \> 2 cm

Elevated alkaline phosphatase \> 2.5 X upper limit of normal (ULN)

Presence of bone metastasis

Presence of peritoneal metastasis

Symptoms due to tumor volume such as pain, fatigue, weight loss, anorexia etc.

Symptoms due to hormone excess requiring active management

Additionally, participants who, in the Investigator's opinion, have high disease burden due to their disease characteristics not specified above could also be considered eligible.

Participants ≥ 12 years of age.

RLI somatostatin receptor (SSTR) uptake on all target lesions (defined by RECIST v1.1 criteria) at least as high as normal liver uptake assessed within 3 months prior to randomization. Any of the RLI modalities as available (some examples are listed below) can be used as per local practice:

\[68Ga\]Ga-DOTA-TOC PET/CT or PET/MRI

\[68Ga\]Ga-DOTA-TATE PET/CT or PET/MRI

\[64Cu\]Cu-DOTA-TATE PET/CT or PET/MRI

Somatostatin receptor scintigraphy (SRS) (planar and/or SPECT/CT) with \[111In\]In-pentetreotide

SRS (planar and/or SPECT/CT) with \[99mTc\]Tc-octreotide.

Adequate bone marrow and organ function as defined by the following laboratory values prior to receiving the first study treatment:

White blood cell (WBC) count ≥ 2 x 109/L

Platelet count ≥ 75 x 109/L

Hemoglobin (Hb) ≥ 8 g/dL

Creatinine clearance \> 40 mL/min calculated by the Cockcroft Gault method

Total bilirubin ≤ 3 x ULN

Potassium within normal limits. Potassium level of up to 6.0 millimoles per liter (mmol/L) is acceptable at study entry if associated with creatinine clearance within normal limits calculated using Cockcroft-Gault formula. Mild decrease (grade 1) below lower limit of normal (LLN) is acceptable at study entry if considered not clinically significant by Investigator.

ECOG performance status 0-1.

Presence of at least 1 measurable site of disease.

Exclusion Criteria

Prior administration of a therapeutic radiopharmaceutical for GEP-NET at any time prior to randomization in the study.

Any previous therapy with interferons, mTOR-inhibitors, chemotherapy or other systemic therapies except somatostatin analogues (SSAs) of GEP-NET. If as per Investigator's opinion a participant is candidate for such therapies, such participant must not be enrolled.

Participant who received more than 4 cycles of prior SSAs (e.g., octreotide long-acting release) are not eligible. In addition, any participant receiving treatment with short-acting octreotide, which cannot be interrupted for 24 h before the administration of \[177Lu\]Lu-DOTA-TATE, or any participant receiving treatment with SSAs, which cannot be interrupted for at least 4 weeks before the administration of \[177Lu\]Lu-DOTA-TATE.

Documented RECIST v1.1 progression during previous SSA treatments for the current GEP-NET at any time prior to randomization.

Any previous radioembolization, chemoembolization and radiofrequency ablation for GEP-NET.

Any major surgery within 12 weeks prior to randomization in the study.

Known brain metastases.

Participant with known intolerance to CT scans with intravenous (i.v.) contrast due to allergic reaction or renal insufficiency. If such a participant can be imaged with MRI, then the participant would not be excluded.

Hypersensitivity to any somatostatin analogues, to the Investigational Medicinal Products (IMPs) active substance or to any of the excipients.

Active severe urinary incontinence, severe voiding dysfunction, or urinary obstruction requiring an indwelling/condom catheter that, in the judgment of the Investigator, could prevent adhering to radiation safety instructions. Other protocol-defined Inclusion/Exclusion criteria may apply.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Denver?

Yes, this clinical trial (NCT06784752) has an active research site in Denver, CO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Neuroendocrine Tumors Treatment Options in Denver, CO

If you're searching for neuroendocrine tumors treatment options in Denver, CO, this clinical trial (NCT06784752) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Denver research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced neuroendocrine tumors specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all neuroendocrine tumors clinical trials near you to find additional studies recruiting in your area.

Neuroendocrine Tumors Clinical Trial in Denver, CO

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