[68Ga]Pentixafor for Neuroendocrine Cancer

Overseen By Kristin Gaimari-Varner, RN, BSN

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Yusuf Menda

Must be taking: Somatostatin analog

Disqualifiers: Active infection, Heart failure, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial uses Gallium-68 Pentixafor, an imaging agent for PET scans, to detect high-grade neuroendocrine tumors. It targets specific markers on these tumors and makes them visible on scans. The study aims to see how consistently this agent works across different scans.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it allows the use of somatostatin analogs during the study.

What data supports the effectiveness of the treatment Gallium-68 Pentixafor for neuroendocrine cancer?

While there is no direct data on Gallium-68 Pentixafor, similar treatments like Gallium-68 DOTATATE have shown effectiveness in accurately locating neuroendocrine tumors, which can help guide surgery. Additionally, treatments like Lutetium-177 DOTATATE have been effective in improving quality of life and slowing disease progression in neuroendocrine tumors. ^{1 2 3 4 5}

How is the drug [68Ga]Pentixafor different from other treatments for neuroendocrine cancer?

The drug [68Ga]Pentixafor is unique because it uses Gallium-68, a radioactive substance, to help visualize neuroendocrine tumors more clearly through PET imaging. This approach offers better resolution and accuracy in detecting tumors compared to older methods that used different radioactive materials. ^{4 6 7 8 9}

Research Team

Yusuf Menda, MD

Principal Investigator

University of Iowa

M. Sue O'Dorisio, MD, PhD

Principal Investigator

University of Iowa

Eligibility Criteria

Adults over 18 with a confirmed neuroendocrine tumor, registered in the Iowa Neuroendocrine Tumor Registry, who've had specific scans within the last 3 months without significant treatment changes. Excludes pregnant women, those planning NET therapy between scans (except for Somatostatin analog), and anyone with illnesses or conditions that could interfere with study participation.

Inclusion Criteria

Results of CXCR4 immunohistochemistry or slides from biopsy of primary tumor or metastatic lesions available for study analysis

Participation in the Iowa Neuroendocrine Tumor Registry

I have a tumor larger than 1.5 cm, confirmed by CT or MRI in the last 3 months.

Exclusion Criteria

Pregnant or lactating women. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A negative pregnancy test will be required for all female subjects with child bearing potential

I am not planning to receive any NET therapy except for Somatostatin analog between two specific scans.

I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

PET Imaging

Participants receive an intravenous administration of [68Ga]Pentixafor followed by PET imaging for about 90 minutes. Blood samples are taken for pharmacokinetic analysis.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging, and repeatability of imaging is assessed.

6 months

Treatment Details

Interventions

• Gallium-68 Pentixafor

Trial Overview [68Ga]Pentixafor's distribution in patients' bodies is being tested to see if it's consistent across multiple scans. This research doesn't apply clinically; images can't be used for medical decisions or shared with oncologists.

Participant Groups

Group I: [68Ga]Pentixafor PET scan Experimental Treatment 1 Intervention

4 mCi (range 3-5 mCi) of \[68Ga\]Pentixafor is administered intravenously over 1 minute using an infusion pump. PET imaging is performed from time of infusion for about 90 minutes. Approximately 12 blood samples (\~ 1 tsp) will be taken for pharmacokinetic analysis.

Who Is Running the Clinical Trial?

Yusuf Menda

Lead Sponsor

Trials

3

Recruited

70+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Holden Comprehensive Cancer Center

Collaborator

Trials

27

Recruited

710+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

In a study of 22 patients with carcinoid syndrome, treatment with 177Lu-DOTATATE significantly reduced bowel movement frequency from an average of 6.1 to 4.6 per day and flushing episodes from 4.3 to 2.4 per day, indicating effective symptom relief.

The therapy also led to a notable decrease in urinary 5-hydroxyindolacetic acid excretion in 56% of patients, suggesting that 177Lu-DOTATATE can be a valuable option for managing symptoms in patients not adequately controlled by somatostatin analogs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peptide Receptor Radionuclide Therapy With 177Lu-DOTATATE for Symptomatic Control of Refractory Carcinoid Syndrome. Zandee, WT., Brabander, T., Blažević, A., et al.[2021]

In a study of 43 patients with advanced gastrointestinal neuroendocrine tumors, (177)Lu-Dotatate peptide receptor radionuclide therapy (Lu-PRRT) demonstrated an 84% disease control rate, with a median response duration of 25 months and a median progression-free survival of 36 months.

Both standard and reduced dosages of Lu-PRRT were found to be safe, as none of the patients experienced side effects, even those at higher risk for kidney or bone marrow toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

177 Lu-Dota-octreotate radionuclide therapy of advanced gastrointestinal neuroendocrine tumors: results from a phase II study. Paganelli, G., Sansovini, M., Ambrosetti, A., et al.[2022]

Radio-guided surgery (RGS) using (68)Ga-DOTATATE is feasible for identifying gastro-entero-pancreatic neuroendocrine tumors (GEPNETs), with an 81% success rate in detecting gastric and small intestine NETs and 67% for pancreatic NETs.

The study involved 14 patients and demonstrated that RGS can accurately confirm the presence of bowel NETs and metastatic lymph nodes, suggesting it could enhance surgical outcomes, although further research is needed to assess its overall benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Radio-Guided Surgery with ⁶⁸Gallium-DOTATATE in Patients with Gastro-Entero-Pancreatic Neuroendocrine Tumors. Sadowski, SM., Millo, C., Neychev, V., et al.[2021]

In a study of 52 patients with advanced pancreatic neuroendocrine tumors, (177)Lu-DOTATATE therapy demonstrated significant antitumor activity, achieving an overall disease control rate of 81% with both full and reduced dosages.

Patients receiving the higher dosage of 27.8 GBq had a longer progression-free survival compared to those on the reduced dosage of 18.5 GBq, suggesting that the higher dose is more effective and is recommended for eligible patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment with the radiolabelled somatostatin analog Lu-DOTATATE for advanced pancreatic neuroendocrine tumors. Sansovini, M., Severi, S., Ambrosetti, A., et al.[2022]

Gallium-68-dotatate PET/CT imaging demonstrated high sensitivity (94.16%) and specificity (91.89%) in detecting neuroendocrine tumors (NET) and other somatostatin expressing tumors, outperforming traditional CT scans.

In a study of 203 patients, PET/CT identified disease in 19 cases where CT was falsely negative, highlighting its superior ability to detect primary tumor sites and inform patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gallium-68-dotatate PET/CT is better than CT in the management of somatostatin expressing tumors: First experience in Africa. Lawal, IO., Ololade, KO., Lengana, T., et al.[2019]

68 Ga-DOTATATE PET/CT imaging proved effective in identifying previously unknown primary tumors and metastatic disease in sinonasal neuroendocrine tumors, highlighting its potential for better diagnosis compared to conventional imaging methods.

In two cases of esthesioneuroblastoma, 68 Ga-DOTATATE detected abnormal uptake that was not visible on 18F-FDG PET/CT, suggesting it may be crucial for treatment planning, including identifying candidates for targeted therapies like 177 Lu-DOTATATE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of 68 Gallium-DOTATATE PET/CT in sinonasal neuroendocrine tumor management: A case series. Liu, KY., Goldrich, DY., Ninan, SJ., et al.[2021]

(68)Ga-DOTATATE PET/CT demonstrated a high sensitivity of 90% and specificity of 82% in detecting recurrent neuroendocrine tumors (NETs) in a study of 63 patients, indicating it is an effective diagnostic tool for monitoring these tumors after curative resection.

The study highlighted that while (68)Ga-DOTATATE PET/CT is accurate, the sensitivity decreased when the scans were reviewed without clinical context, emphasizing the importance of integrating clinical information in the evaluation of NET recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroendocrine tumor recurrence: diagnosis with 68Ga-DOTATATE PET/CT. Haug, AR., Cindea-Drimus, R., Auernhammer, CJ., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Peptide Receptor Radionuclide Therapy With 177Lu-DOTATATE for Symptomatic Control of Refractory Carcinoid Syndrome. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

177 Lu-Dota-octreotate radionuclide therapy of advanced gastrointestinal neuroendocrine tumors: results from a phase II study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Effective treatment of bone metastases from a neuroendocrine tumour of the pancreas with high activities of Indium-111-pentetreotide. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Feasibility of Radio-Guided Surgery with ⁶⁸Gallium-DOTATATE in Patients with Gastro-Entero-Pancreatic Neuroendocrine Tumors. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Treatment with the radiolabelled somatostatin analog Lu-DOTATATE for advanced pancreatic neuroendocrine tumors. [2022]

6. Greece pubmed.ncbi.nlm.nih.gov

Gallium-68 PET: a new frontier in receptor cancer imaging. [2022]

7. Greece pubmed.ncbi.nlm.nih.gov

Gallium-68-dotatate PET/CT is better than CT in the management of somatostatin expressing tumors: First experience in Africa. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

The value of 68 Gallium-DOTATATE PET/CT in sinonasal neuroendocrine tumor management: A case series. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Neuroendocrine tumor recurrence: diagnosis with 68Ga-DOTATATE PET/CT. [2022]